Non‐invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema

Flávia MR Vital; Magdaline T Ladeira; Álvaro N Atallah

doi:10.1002/14651858.CD005351.pub3

Cochrane Database of Systematic Reviews

Ventilación no invasiva con presión positiva (PPCVR o VNIPP a dos niveles) para el edema pulmonar cardiogénico

Información

DOI:

https://doi.org/10.1002/14651858.CD005351.pub3 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

31 mayo 2013see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Corazón

Copyright:

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

Flávia MR Vital

Correspondencia a: Department of Physiotherapy, Muriaé Cancer Hospital, Muriaé, Brazil

[email protected]

[email protected]
Magdaline T Ladeira

Department of Internal and Therapeutic Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil
Álvaro N Atallah

Brazilian Cochrane Centre, Centro de Estudos de Medicina Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil

Contributions of authors

Flávia Vital did the protocol conceiving, designing, coordinating and writing and did the following tasks: selection of studies, quality evaluation, extraction and analysis data, final report and completion of the Cochrane publication and updating.

Álvaro Atallah did the protocol writing and did the following tasks: data analysis, final report and completion of the Cochrane publication and updating. Expertise advice.

Magdaline Ladeira did the protocol writing and the following tasks: selection of studies, quality evaluation, completion of the Cochrane publication and updating.

Sources of support

Internal sources

Department of Urgency Medicine, Universidade Federal de São Paulo, Brazil.
Brazilian Cochrane Centre, Brazil.

External sources

No sources of support supplied

Declarations of interest

None known.

Acknowledgements

We are grateful to the authors of the studies we reviewed and who kindly answered our e‐mails or correspondence regarding additional data (Räsänen, Bersten, Kelly, Nava, Park, Takeda, Thys, Masip, Bellone, Crane, Delclaux, Ferrari, Bautin, Agmy, Gray and Weitz). We are also thankful for the critical evaluation of the professors Dr. Velasco IT, Dr. Scalabrini Neto A, Dr. Gonçalves AJ, Dr. Godoy MF and by the collaboration of the following co‐authors in the first version of the publication of this systematic review: Burns K, Saconato H, Sen A, Hawkes CA and Soares B. We thank Joey Kwong by Chinese translation paper. Finally the Cochrane heart group for suggested improvements.

Version history

Published

Title

Stage

Authors

Version

2019 Apr 05

Non‐invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema

Review

Nicolas Berbenetz, Yongjun Wang, James Brown, Charlotte Godfrey, Mahmood Ahmad, Flávia MR Vital, Pier Lambiase, Amitava Banerjee, Ameet Bakhai, Matthew Chong

https://doi.org/10.1002/14651858.CD005351.pub4

2013 May 31

Non‐invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema

Review

Flávia MR Vital, Magdaline T Ladeira, Álvaro N Atallah

https://doi.org/10.1002/14651858.CD005351.pub3

2008 Jul 16

Non‐invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema

Review

Flávia MR Vital, Humberto Saconato, Magdaline T Ladeira , Ayan Sen, Claire A Hawkes, Bernardo Soares, Karen E. A. Burns, Álvaro N Atallah

https://doi.org/10.1002/14651858.CD005351.pub2

2005 Jul 20

Non‐invasive positive pressure ventilation (CPAP or BiPAP) in cardiogenic pulmonary oedema

Protocol

Flávia MR Vital, Ayan Sen, Álvaro N Atallah, Magdaline Trindade T Ladeira, Bernardo Garcia de Oliveira Soares, Karen E A Burns, C Hawkes

https://doi.org/10.1002/14651858.CD005351

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

QUOROM statement flow diagram of 2005

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Figure 2

Figure 4. PRISMA statement flow diagram of 2011

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 5

Funnel plot of comparison: 1 Hospital Mortality, outcome: 1.1 NPPV (CPAP and BILEVEL) x SMC.

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Figure 6

Cumulative meta‐analysis

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Analysis 1.1

Comparison 1 Hospital mortality, Outcome 1 NPPV (CPAP and BILEVEL) x SMC.

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Analysis 1.2

Comparison 1 Hospital mortality, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

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Analysis 1.3

Comparison 1 Hospital mortality, Outcome 3 NPPV (CPAP and BILEVEL) X SMC‐ ED place.

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Analysis 1.4

Comparison 1 Hospital mortality, Outcome 4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place.

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Analysis 1.5

Comparison 1 Hospital mortality, Outcome 5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline.

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Analysis 1.6

Comparison 1 Hospital mortality, Outcome 6 CPAP x SMC.

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Analysis 1.7

Comparison 1 Hospital mortality, Outcome 7 CPAP X SMC ‐ sensitivity analysis.

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Analysis 1.8

Comparison 1 Hospital mortality, Outcome 8 BILEVEL X SMC.

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Analysis 1.9

Comparison 1 Hospital mortality, Outcome 9 BILEVEL X SMC ‐ sensitivity analysis.

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Analysis 1.10

Comparison 1 Hospital mortality, Outcome 10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline.

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Analysis 1.11

Comparison 1 Hospital mortality, Outcome 11 BILEVEL X SMC ‐ in patients hypercanics.

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Analysis 1.12

Comparison 1 Hospital mortality, Outcome 12 CPAP X BILEVEL.

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Analysis 1.13

Comparison 1 Hospital mortality, Outcome 13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline.

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Analysis 1.14

Comparison 1 Hospital mortality, Outcome 14 CPAP X BILEVEL ‐ in patients hypercanics.

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Analysis 2.1

Comparison 2 EETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 2.2

Comparison 2 EETI rate, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

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Analysis 2.3

Comparison 2 EETI rate, Outcome 3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline.

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Analysis 2.4

Comparison 2 EETI rate, Outcome 4 CPAP X SMC.

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Analysis 2.5

Comparison 2 EETI rate, Outcome 5 CPAP X SMC ‐ sensitivity analysis.

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Analysis 2.6

Comparison 2 EETI rate, Outcome 6 BILEVEL X SMC.

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Analysis 2.7

Comparison 2 EETI rate, Outcome 7 BILEVEL X SMC ‐ sensitivity analysis.

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Analysis 2.8

Comparison 2 EETI rate, Outcome 8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline.

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Analysis 2.9

Comparison 2 EETI rate, Outcome 9 BILEVEL X SMC ‐ in patients hypercapnics.

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Analysis 2.10

Comparison 2 EETI rate, Outcome 10 CPAP X BILEVEL.

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Analysis 2.11

Comparison 2 EETI rate, Outcome 11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline.

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Analysis 2.12

Comparison 2 EETI rate, Outcome 12 CPAP X BILEVEL ‐ in patients hypercapnics.

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Analysis 3.1

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 3.2

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 2 CPAP X SMC.

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Analysis 3.3

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 3 BILEVEL X SMC.

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Analysis 3.4

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 4 CPAP X BILEVEL.

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Analysis 3.5

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 5 BILEVEL X SMC ‐ heterogeneity analysis.

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Analysis 4.1

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 4.2

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 2 CPAP X SMC.

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Analysis 4.3

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 3 BILEVEL X SMC.

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Analysis 4.4

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 4 CPAP X BILEVEL.

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Analysis 5.1

Comparison 5 Intolerance to allocated treatment, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 5.2

Comparison 5 Intolerance to allocated treatment, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

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Analysis 5.3

Comparison 5 Intolerance to allocated treatment, Outcome 3 CPAP X SMC.

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Analysis 5.4

Comparison 5 Intolerance to allocated treatment, Outcome 4 BILEVEL X SMC.

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Analysis 5.5

Comparison 5 Intolerance to allocated treatment, Outcome 5 CPAP X BILEVEL.

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Analysis 6.1

Comparison 6 Hospital length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 6.2

Comparison 6 Hospital length of stay, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

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Analysis 6.3

Comparison 6 Hospital length of stay, Outcome 3 CPAP X SMC.

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Analysis 6.4

Comparison 6 Hospital length of stay, Outcome 4 BILEVEL X SMC.

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Analysis 6.5

Comparison 6 Hospital length of stay, Outcome 5 CPAP X BILEVEL.

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Analysis 7.1

Comparison 7 ICU length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 7.2

Comparison 7 ICU length of stay, Outcome 2 CPAP X SMC.

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Analysis 7.3

Comparison 7 ICU length of stay, Outcome 3 BILEVEL X SMC.

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Analysis 7.4

Comparison 7 ICU length of stay, Outcome 4 CPAP X BILEVEL.

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Analysis 8.1

Comparison 8 Breath rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 8.2

Comparison 8 Breath rate after one hour, Outcome 2 CPAP X SMC.

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Analysis 8.3

Comparison 8 Breath rate after one hour, Outcome 3 BILEVEL X SMC.

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Analysis 8.4

Comparison 8 Breath rate after one hour, Outcome 4 CPAP X BILEVEL.

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Analysis 9.1

Comparison 9 Heart rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 9.2

Comparison 9 Heart rate after one hour, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

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Analysis 9.3

Comparison 9 Heart rate after one hour, Outcome 3 CPAP X SMC.

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Analysis 9.4

Comparison 9 Heart rate after one hour, Outcome 4 CPAP X SMC ‐ heterogeneity analysis.

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Analysis 9.5

Comparison 9 Heart rate after one hour, Outcome 5 BILEVEL X SMC.

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Analysis 9.6

Comparison 9 Heart rate after one hour, Outcome 6 CPAP X BILEVEL.

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Analysis 10.1

Comparison 10 Sistolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 10.2

Comparison 10 Sistolic blood pressure after one hour, Outcome 2 CPAP X SMC.

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Analysis 10.3

Comparison 10 Sistolic blood pressure after one hour, Outcome 3 BILEVEL X SMC.

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Analysis 10.4

Comparison 10 Sistolic blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

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Analysis 10.5

Comparison 10 Sistolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL ‐ heterogeneity analysis.

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Analysis 11.1

Comparison 11 Diastolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 11.2

Comparison 11 Diastolic blood pressure after one hour, Outcome 2 CPAP X SMC.

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Analysis 11.3

Comparison 11 Diastolic blood pressure after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

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Analysis 11.4

Comparison 11 Diastolic blood pressure after one hour, Outcome 4 BILEVEL X SMC.

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Analysis 11.5

Comparison 11 Diastolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL.

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Analysis 11.6

Comparison 11 Diastolic blood pressure after one hour, Outcome 6 CPAP X BILEVEL ‐ heterogeneity analysis.

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Analysis 12.1

Comparison 12 Mean blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 12.2

Comparison 12 Mean blood pressure after one hour, Outcome 2 CPAP X SMC.

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Analysis 12.3

Comparison 12 Mean blood pressure after one hour, Outcome 3 BILEVEL X SMC.

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Analysis 12.4

Comparison 12 Mean blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Analysis 13.1

Comparison 13 PaO₂ (mmHg) after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 2 CPAP X SMC.

Analysis 13.2

Comparison 13 PaO₂ (mmHg) after one hour, Outcome 2 CPAP X SMC.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

Analysis 13.3

Comparison 13 PaO₂ (mmHg) after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 4 BILEVEL X SMC.

Analysis 13.4

Comparison 13 PaO₂ (mmHg) after one hour, Outcome 4 BILEVEL X SMC.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 5 CPAP X BILEVEL.

Analysis 13.5

Comparison 13 PaO₂ (mmHg) after one hour, Outcome 5 CPAP X BILEVEL.

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Analysis 14.1

Comparison 14 Adverse events, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 14.2

Comparison 14 Adverse events, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000.

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Analysis 14.3

Comparison 14 Adverse events, Outcome 3 CPAP X SMC.

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Analysis 14.4

Comparison 14 Adverse events, Outcome 4 BILEVEL X SMC.

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Analysis 14.5

Comparison 14 Adverse events, Outcome 5 CPAP X BILEVEL.

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Analysis 15.1

Comparison 15 Hospital or 7‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 16.1

Comparison 16 Hospital or 30‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Analysis 17.1

Comparison 17 General or 7‐day ETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Summary of findings for the main comparison. Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV) for cardiogenic pulmonary edema

Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV) for cardiogenic pulmonary oedema
Patient or population: patients with cardiogenic pulmonary oedema Settings: Emergency Department or Intensive Care Unit Intervention: Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV)
Hospital mortalityY	Study population¹		RR 0.66 (0.48 to 0.89)	1107 (20 studies)	⊕⊕⊕⊕ high^2,3
	204 per 1000	135 per 1000 (98 to 182)
	Moderate¹
	200 per 1000	132 per 1000 (96 to 178)
Endotracheal intubation rate	Study population		RR 0.52 (0.36 to 0.75)	1261 (22 studies)	⊕⊕⊝⊝ low^4,5
	249 per 1000	130 per 1000 (90 to 187)
	Moderate
	300 per 1000	156 per 1000 (108 to 225)
Incidence of acute myocardial infarction (During intervention)	Study population		RR 1.24 (0.79 to 1.95)	461 (8 studies)	⊕⊕⊕⊝ moderate^5,6
	153 per 1000	190 per 1000 (121 to 299)
	Moderate
	169 per 1000	210 per 1000 (134 to 330)
Incidence of acute myocardial infarction (After intervention)	Study population		RR 0.7 (0.11 to 4.26)	154 (4 studies)	⊕⊝⊝⊝ very low^5,7
	26 per 1000	18 per 1000 (3 to 111)
	Moderate
	13 per 1000	9 per 1000 (1 to 55)
Intolerance to allocated treatment	Study population		RR 0.47 (0.29 to 0.77)	1848 (13 studies)	⊕⊕⊕⊝ moderate^8,9,10
	234 per 1000	110 per 1000 (68 to 180)
	Moderate
	350 per 1000	165 per 1000 (101 to 269)
Hospital length of stay		The mean hospital length of stay in the intervention groups was 0.8 lower (2.1 lower to 0.51 higher)		542 (10 studies)	⊕⊝⊝⊝ very low^11,12
Intensive care unit length of stay (Copy)		The mean intensive care unit length of stay (copy) in the intervention groups was 0.89 lower (1.33 to 0.45 lower)		222 (6 studies)	⊕⊕⊝⊝ low^5,13
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ The most studies have mixed populations (with different levels of severity and co‐morbidities). ² Was included only two quasi‐randomised trials, but sensitivity analysis with quasi‐randomised studies exclusion (Bersten 1991; Weitz 2007), showed the results to remain statistically significant. L'Her 2004 was interrupted early due to a greater number in deaths and complications in the control group. ³ Although there is less 300 events in meta‐analysis, when add Gray's study that analysed the mortality in 30 days, our meta‐analysis of hospital mortality show that these study reinforce the favourable use of NPPV in ACPE with more 300 events. ⁴ Was included only two quasi‐randomised trials, but sensitivity analysis with quasi‐randomised studies exclusion (Bersten 1991; Weitz 2007), showed the results to remain statistically significant. Park 2004 was interrupted early due to a difference in the frequency of intubations. Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention. ⁵ There is less 300 events in meta‐analysis. ⁶ Although two studies (Sharon 2000; Thys 2002) were interrupted early due to the incidence of acute myocardial infarction and the second due to a batch of failures of treatment and clinical decline. ⁷ Was included one quasi‐randomised trial (Weitz 2007). Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention. ⁸ Was included two quasi‐randomised trials (Bersten 1991; Weitz 2007). L'Her 2004 was interrupted early due to a greater number in deaths and complications in the control group and not present the results in relation to autonomy for the activities of daily living, patient comfort and some planned adverse effects to be observed. Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention. Thys 2002 was interrupted early due to a batch of failures of treatment and clinical decline. ⁹ The grouping of the studies demonstrated relevant heterogeneity which was eliminated with the exclusion of Gray 2008 study, but we have not found plausible justification for this result ¹⁰ RR < 0.5 ¹¹ Was included two quasi‐randomised trials (Bersten 1991; Weitz 2007). L'Her 2004 and Thys 2002 were interrupted early, the first due to a greater number in deaths and in the control group and the second due to a batch of failures of treatment and clinical decline. L'Her 2004 did not present the results in relation to autonomy for the activities of daily living, patient comfort and some planned adverse effects to be observed. Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention. ¹² The grouping of the studies demonstrated relevant heterogeneity. ¹³ Was included two quasi‐randomised trials (Bersten 1991; Weitz 2007). Thys 2002 was interrupted early due to a batch of failures of treatment and clinical decline.

Summary of findings for the main comparison. Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV) for cardiogenic pulmonary edema

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Table 1. IPAP Level and EPAP Level and time of intervention

Study	IPAP level (cmH₂O)	EPAP in bievel NPPV (cmH₂O)	PEEP in CPAP (cmH₂O)	Time of bilevel NPPV (hours)	Time of CPAP (hours)
Bautin 2005	5.1 (SD 0.3)	9.8 (SD 1.1)
Bellone 2004		5	10	1.6 (SD 0.6)	1.7 (SD 0.7)
Bellone 2005		5	10	3.41 (SD 1.1)	3.6 (SD 1.3)
Bersten 1991			10		9.3 (SD 4.9)
Crane 2004	15	5	10
Ferrari 2007	15 (SD 3.1)	7 (SD 1.2)	8.8 (SD 1.9)	6.0 (SD 4.7)	8.1 (SD 8.3)
Ferrari 2009	14 (SD 3.1)	6.7 (SD 1.4)	8.8 (SD 1.7)	5.9 (SD 4.0)	8.4 (SD 7.1)
Fontanella 2010	18 (SD 3)	10 (SD 2)	8 (SD 2)
Frontin 2010			10
Gray 2009	14 (SD 5)	7 (SD 3)	10 (SD 4)	2.0 (SD 1.3)	2.2 (SD 1.5)
Kelly 2002			7.5
L'Her 2004			7.5		8 (SD 6)
Liesching 2003	12	4	10
Martin‐Bermudez 2002				1.3 (SD 0.8)	1.8 (SD 1)
Masip 2000	15.2 (SD 2.4)	5		4.2 (SD 1.5)
Mehta 1997	14.35 (SD 1.73)	5	10.08 (SD 1.24)	7.1 (SD 4.7)	6.4 (SD 5.8)
Moritz 2007	12 (SD 3.2)	4.9 (SD 0.9)	7.7 (SD 2.1)	2.8	2.3
Nava 2003	14.5 (SD 21.1)	6.1 (SD 3.2)		11.4 (SD 3.6)
Park 2001	12	4	7.5	2.5 (SD 0.6)	2.8 (SD 1.5)
Park 2004	17 (SD 2)	11 (SD 2)	11 (SD 2)	2.0 (SD 1.0)	1.7 (SD 0.6)
Rasanen 1985			10
Sharon 2000	9.3 (SD 2.3)	4.2 (SD 3.1)
Takeda 1997					11.9 (SD 8.4)
Thys 2002	16.5 (SD 3.3)	6.1 (SD 1.5)		1.2 (SD 0.2)
Weitz 2007	12.5 (SD 1.2)	5
CPAP ‐ continuous positive airway pressure; EPAP ‐ expiratory positive airway pressure; IPAP ‐ inspiratory positive airway pressure; PEEP ‐ positive expiratory end pressure; SD ‐ standard deviation; * statistically significant.

Table 1. IPAP Level and EPAP Level and time of intervention

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Table 2. Summary of adverse events

Adverse events	Number of events (CPAP)	Total number CPAP	Number of event (bilevel NPPV)	Total number (bilevel NPPV)	RR (95% CI)
Skin damage	2	472	17	458	0.06 (0.01, 0.43)*
Pneumonia	0	40	1	76	0.63 (0.03, 15.03)
Pulmonary aspiration	0	476	1	383	0.27 (0.01, 6.57)
Gastric distention	5	178	8	51	0.18 (0.06, 0.52)*
GI bleeding	0	11	3	85	1.02 (0.06, 18.63)
Vomitting	7	381	9	419	0.86 (0.32, 2.27)
Pneumothorax	0	440	1	430	0.33 (0.01, 7.97)
Asphyxia/claustrophobia	0	20	1	65	1.05 (0.04, 24.76)
Mask discomfort	15	364	22	440	0.82 (0.43, 1.57)
Sinusitis	0	43	1	65	0.50 (0.02, 12.00)
Conjunctivitis	0	70
Eye irritation			0	20
Cardiac arrest	6	333	13	410	0.57 (0.22, 1.48)
Stroke			0	65
Seizure			0	65
Hypotension	36	332	37	346	1.01 (0.66, 1.56)
Arrhythmia requiring treatment	12	332	25	345	0.50 (0.25, 0.98)*
Progressive respiratory distress	17	333	21	346	0.84 (0.45, 1.57)
Increase breathing discomfort	16	287	19	291	0.85 (0.45, 1.63)
CI ‐ confidence interval; CPAP ‐ continuous positive airway pressure; RR ‐ relative risk; SD ‐ standard deviation; * statistically significant..

Table 2. Summary of adverse events

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Table 3. Adverse events by NPPV versus SMC

Adverse events	Studies	NPPV group	SMC group	RR (95% CI)
Skin damage	11 studies (Rasanen 1985, Bersten 1991, Takeda 1998, Masip 2000, Kelly 2002, Thys 2002, Nava 2003, Crane 2004, L'Her 2004, Park 2004, Bautin 2005)	17/318	0/276	6.62 (1.20, 36.55)*
Pneumonia	3 study (Lin 1991, Nava 2003, Bautin 2005)	1/116	4/116	0.35 (0.05, 2.20)
Pulmonary aspiration	5 studies (Rasanen 1985, Bersten 1991, Lin 1991, Kelly 2002, Gray 2008)	1/787	0/468	1.58 (0.06, 38,61)
Gastrointestinal bleeding	3 study (Takeda 1998, Masip 2000, Nava 2003)	3/96	2/96	1,37 (0.27, 6.89)
Gastric distension	8 studies (Rasanen 1985, Bersten 1991, Lin 1991, Takeda 1998, Thys 2002, Park 2004, L'Her 2004, Frotin 2010)	13/253	0/231	13.26 ( 0.82, 215.12)
Vomiting	5 studies (Masip 2000, Thys 2002, Crane 2004, Park 2004, Gray 2008)	16/800	8/429	1.06 (0.46, 2.47)
Asphyxia	2 study (Bersten 1991, Nava 2003)	1/85	0/85	3.00 (0.12, 72.31)
Pneumothorax	6 studies (Bersten 1991, Kelly 2002, Nava 2003, L'Her 2004, Gray 2008, Frotin 2010)	1/894	1/580	0.72 (0.08, 6.89)
Conjunctivitis	2 studies (Kelly 2002, L'Her 2004)	0/70	0/77	inestimable
Sinusitis	2 study (Nava 2003, L'Her 2004)	1/108	0/111	3.00 (0.12, 72.31)
Mask discomfort	7 study (Masip 2000, Nava 2003, L'Her 2004, Park 2004, Bautin 2005, Weitz 2007, Frotin 2010)	7/265	0/247	5.39 (0.97, 30.09)
Hypotension	1 study (Gray 2008)	73/678	46/352	0.82 (0.58, 1.16)
Arrhythmia	1 study (Gray 2008)	37/677	23/350	0.83 (0.50, 1.38)
Progressive respiratory distress	2 studies (L'Her 2004, Gray 2008)	39/722	36/400	0.58 (0.37, 0.89)*
Neurological failure (coma)	1 study (L'Her 2004)	1/44	11/46	0,10 (0.01, 0,71)*
Cardiorespiratory arrest	3 studies (Nava 2003, L'Her 2004, Gray 2008)	21/786	22/466	0.60 (0.29, 1.26)
Eye irritation	1 study (Masip 2000)	0/20	0/20	inestimable
Stroke	1 study (Nava 2003)	0/65	0/65	inestimable
Seizure	1 study (Nava 2003)	0/65	1/65	0.33 (0.01, 8.03)
CI ‐ confidence interval; NPPV ‐ noninvasive positive pressure ventilation; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Table 3. Adverse events by NPPV versus SMC

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Table 4. Adverse events by CPAP versus SMC

Adverse Events	Studies	CPAP group	SMC group	RR (95% CI)
Skin damage	7 studies (Rasanen 1985, Bersten 1991, Takeda 1998, Kelly 2002, Crane 2004, L'Her 2004, and Park 2004)	1/168	0/175	3.00 (0.13, 69.52)
Pneumonia	1 study (Lin 1991)	0/40	0/40	inestimable
Pulmonary aspiration	5 studies (Rasanen 1985, Bersten 1991, Lin 1991, Kelly 2002, Gray 2008)	0/440	0/468	inestimable
Gastrointestinal bleeding	1 study (Takeda 1998)	0/11	1/11	0.33 (0.02,7.39)
Gastric distension	7 studies (Rasanen 1985, Bersten 1991, Lin 1991, Takeda 1998, Park 2004, L'Her 2004, Frotin 2010)	5/221	0/226	11.00 ( 0.64, 189.65)
Vomiting	3 studies (Crane 2004, Park 2004, Gray 2008)	7/381	8/404	0.93 (0.34, 2.54)
Asphyxia	1 study (Bersten 1991)	0/20	0/20	inestimable
Pneumothorax	5 studies (Bersten 1991, Kelly 2002, L'Her 2004, Gray 2008, Frotin 2010)	0/483	0/515	inestimable
Conjunctivitis	2 studies (Kelly 2002, L'Her 2004)	0/70	0/77	inestimable
Sinusitis	1 study (L'Her 2004)	0/43	0/46	inestimable
Mask discomfort	3 studies (L'Her 2004, Park 2004, Frotin 2010)	0/130	0/135	inestimable
Hypotension	1 study (Gray 2008)	36/332	46/352	0.83 (0.55, 1.25)
Arrhythmia	1 study (Gray 2008)	12/332	23/350	0.55 (0.28, 1.09)
Progressive respiratory distress	2 studies (L'Her 2004, Gray 2008)	18/376	36/400	0.53 (0.31, 0.92)*
Neurological failure (coma)	1 study (L'Her 2004)	1/44	11/46	0,10 (0.01, 0,71)*
Cardiorespiratory arrest	2 studies (L'Her 2004, Gray 2008)	8/376	21/401	0.41 (0.18, 0.91)*
CI ‐ confidence interval; CPAP ‐ continuous positive airway pressure; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Table 4. Adverse events by CPAP versus SMC

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Table 5. Adverse events by bilevel NPPV versus SMC

Adverse Events	Studies	Bilevel NPPV Group	SMC Group	RR (95% CI)
Skin damage	6 studies (Masip 2000, Thys 2002, Nava 2003, Crane 2004, Park 2004, Bautin 2005)	16/148	0/148	7.16 (1.27, 40.50)*
Pneumonia	2 study (Nava 2003, Bautin 2005)	1/76	4/76	0.35 (0.05, 2.20)
Gastrointestinal bleeding	2 studies (Nava 2003, Masip 2000)	3/85	1/85	2.32 (0.35, 15.42)
Gastric distension	2 studies (Thys 2002, Park 2004)	8/32	0/32	15.87 (0.96, 262.30)
Vomiting	5 studies (Masip 2000, Thys 2002, Crane 2004, Park 2004, Gray 2008)	9/419	8/429	1.21 (0.47, 3.11)
Pneumothorax	2 study (Nava 2003, Gray 2008)	1/411	1/421	1.01 (0.11, 9.63)
Eye irritation	1 study (Masip 2000)	0/20	0/20	inestimable
Sinusitis	1 study (Nava 2003)	1/65	0/65	3.00 (0.12, 72.31)
Mask discomfort	5 studies (Masip 2000, Nava 2003, Park 2004, Bautin 2005, Weitz 2007)	7/135	0/139	5.39 (0.97, 30.09)
Claustrophobia	1 study (Nava 2003)	1/65	0/65	3.00 (0.12, 72.31)
Cardiac arrest	2 study (Nava 2003, Gray 2008)	13/410	17/420	0.96 (0.25, 3.61)
Stroke	1 study (Nava 2003)	0/65	0/65	inestimable
Seizure	1 study (Nava 2003)	0/65	1/65	0.33 (0.01, 8.03)
Pulmonary aspiration	1 studies (Gray 2008)	1/347	0/357	3.09 (0.13, 75.50)
Hypotension	1 study (Gray 2008)	37/346	46/352	0.82 (0.54, 1.23)
Arrhythmia	1 study (Gray 2008)	25/345	23/350	1.10 (0.64, 1.90)
Progressive respiratory distress	1 study (Gray 2008)	21/346	35/354	0.61 (0.36, 1.03)
CI ‐ confidence interval; NPPV ‐ noninvasive positive pressure ventilation; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Table 5. Adverse events by bilevel NPPV versus SMC

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Table 6. Adverse events by bilevel NPPV versus CPAP

Adverse events	Sstudies	Bilevel NPPV group	CPAP group	RR (95% CI)
Skin damage	5 studies (Mehta 1997, Martin‐Bermudez 2002, Crane 2004, Park 2004, Gray 2008)	4/400	6/390	0.64 (0.19, 2.16)
Pulmonary aspiration	3 studies (Mehta 1997, Martin‐Bermudez 2002, Gray 2008)	1/407	0/389	2.88 (0.12, 70.43)
Gastric distension	3 studies (Mehta 1997, Martin‐Bermudez 2002, Park 2004)	8/89	5/83	1.49 (0.56, 4.00)
Vomiting	4 studies (Martin‐Bermudez 2002, Crane 2004, Park 2004, Gray 2008)	11/437	11/420	0.97 (0.43, 2.19)
Pneumothorax	2 studies (Mehta 1997, Gray 2008)	1/365	0/350	2.89 (0.12, 70.63)
Mask discomfort	4 studies (Mehta 1997, Martin‐Bermudez 2002, Park 2004, Gray 2008)	17/375	16/360	1.03 (0.53, 2.00)
Increased breathing discomfort	1 study (Gray 2008)	16/291	11/285	1.42 (0.67, 3.02)
Hypotension	2 studies (Martin‐Bermudez 2002, Gray 2008)	41/387	40/371	0.98 (0.65, 1.48)
Arrhythmia	1 study (Gray 2008)	25/345	12/332	2.00 (1.02, 3.92)*
Progressive respiratory distress	1 study (Gray 2008)	21/346	17/333	1.19 (0.64, 2.21)
Cardiorespiratory arrest	1 study (Gray 2008)	10/345	6/333	1.61 (0.59, 4.38)
Pharyngeal damage	1 study (Martin‐Bermudez 2002)	1/41	1/39	0.95 (0.06, 14.69)
Cough	1 study (Martin‐Bermudez 2002)	1/41	1/39	0.32 (0.01, 7.57)
CI ‐ confidence interval; CPAP ‐ continuous positive airway pressure; NPPV ‐ noninvasive positive pressure ventilation; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Table 6. Adverse events by bilevel NPPV versus CPAP

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Comparison 1. Hospital mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) x SMC Show forest plot	20	1107	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.48, 0.89]

2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis Show forest plot	18	1023	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.46, 0.91]

3 NPPV (CPAP and BILEVEL) X SMC‐ ED place Show forest plot	9	717	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.36, 0.86]

4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place Show forest plot	7	365	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.28, 0.83]

5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline Show forest plot	9	603	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.40, 0.88]

6 CPAP x SMC Show forest plot	13	699	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.39, 0.94]

7 CPAP X SMC ‐ sensitivity analysis Show forest plot	12	659	Risk Difference (M‐H, Random, 95% CI)	‐0.12 [‐0.19, ‐0.04]

8 BILEVEL X SMC Show forest plot	11	506	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.39, 1.09]

9 BILEVEL X SMC ‐ sensitivity analysis Show forest plot	9	458	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.37, 1.09]

10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline Show forest plot	7	401	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.34, 1.02]

11 BILEVEL X SMC ‐ in patients hypercanics Show forest plot	2	104	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.04, 0.86]

12 CPAP X BILEVEL Show forest plot	12	694	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.61, 1.97]

13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline Show forest plot	9	518	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.45, 2.14]

14 CPAP X BILEVEL ‐ in patients hypercanics Show forest plot	2	98	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.33, 3.37]

Comparison 1. Hospital mortality

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Comparison 2. EETI rate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	22	1261	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.36, 0.75]

2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis Show forest plot	20	1195	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.37, 0.78]

3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline Show forest plot	9	621	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.25, 0.77]

4 CPAP X SMC Show forest plot	14	825	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.33, 0.67]

5 CPAP X SMC ‐ sensitivity analysis Show forest plot	13	785	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.34, 0.67]

6 BILEVEL X SMC Show forest plot	12	536	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.26, 1.17]

7 BILEVEL X SMC ‐ sensitivity analysis Show forest plot	10	470	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.26, 0.80]

8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline Show forest plot	7	401	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.22, 0.97]

9 BILEVEL X SMC ‐ in patients hypercapnics Show forest plot	3	120	Risk Ratio (M‐H, Random, 95% CI)	0.28 [0.12, 0.69]

10 CPAP X BILEVEL Show forest plot	13	721	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.55, 1.97]

11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline Show forest plot	9	518	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.58, 2.33]

12 CPAP X BILEVEL ‐ in patients hypercapnics Show forest plot	2	98	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.26, 3.21]

Comparison 2. EETI rate

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Comparison 3. Incidence of acute myocardial infarction (during intervention)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	8	461	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.79, 1.95]

2 CPAP X SMC Show forest plot	3	152	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.37, 2.24]

3 BILEVEL X SMC Show forest plot	7	356	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.78, 2.49]

4 CPAP X BILEVEL Show forest plot	7	409	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.39, 1.10]

5 BILEVEL X SMC ‐ heterogeneity analysis Show forest plot	6	316	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.69, 1.88]

Comparison 3. Incidence of acute myocardial infarction (during intervention)

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Comparison 4. Incidence of acute myocardial infarction (after intervention)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	4	154	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.11, 4.26]

2 CPAP X SMC Show forest plot	2	99	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.11, 10.23]

3 BILEVEL X SMC Show forest plot	3	65	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.02, 11.54]

4 CPAP X BILEVEL Show forest plot	2	68	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.57, 4.32]

Comparison 4. Incidence of acute myocardial infarction (after intervention)

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Comparison 5. Intolerance to allocated treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	13	1848	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.29, 0.77]

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot	12	692	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.30, 0.58]

3 CPAP X SMC Show forest plot	9	1304	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.36, 0.85]

4 BILEVEL X SMC Show forest plot	7	995	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.24, 1.42]

5 CPAP X BILEVEL Show forest plot	3	894	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.35, 2.53]

Comparison 5. Intolerance to allocated treatment

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Comparison 6. Hospital length of stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	10	542	Mean Difference (IV, Random, 95% CI)	‐0.80 [‐2.10, 0.51]

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot	9	519	Mean Difference (IV, Random, 95% CI)	‐0.38 [‐1.35, 0.58]

3 CPAP X SMC Show forest plot	5	337	Mean Difference (IV, Random, 95% CI)	‐0.51 [‐1.69, 0.67]

4 BILEVEL X SMC Show forest plot	7	311	Mean Difference (IV, Random, 95% CI)	‐1.38 [‐3.38, 0.62]

5 CPAP X BILEVEL Show forest plot	6	402	Mean Difference (IV, Random, 95% CI)	‐0.46 [‐1.99, 1.07]

Comparison 6. Hospital length of stay

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Comparison 7. ICU length of stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	6	222	Mean Difference (IV, Random, 95% CI)	‐0.89 [‐1.33, ‐0.45]

2 CPAP X SMC Show forest plot	3	169	Mean Difference (IV, Random, 95% CI)	‐1.09 [‐1.63, ‐0.56]

3 BILEVEL X SMC Show forest plot	3	53	Std. Mean Difference (IV, Random, 95% CI)	‐0.65 [‐1.37, 0.06]

4 CPAP X BILEVEL Show forest plot	3	159	Mean Difference (IV, Random, 95% CI)	0.31 [‐0.78, 1.40]

Comparison 7. ICU length of stay

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Comparison 8. Breath rate after one hour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	9	438	Mean Difference (IV, Random, 95% CI)	‐2.86 [‐3.85, ‐1.87]

2 CPAP X SMC Show forest plot	7	300	Mean Difference (IV, Random, 95% CI)	‐2.39 [‐3.70, ‐1.07]

3 BILEVEL X SMC Show forest plot	6	254	Mean Difference (IV, Random, 95% CI)	‐3.52 [‐4.80, ‐2.23]

4 CPAP X BILEVEL Show forest plot	5	218	Mean Difference (IV, Random, 95% CI)	0.57 [1.00, 2.13]

Comparison 8. Breath rate after one hour

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Comparison 9. Heart rate after one hour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	9	438	Mean Difference (IV, Random, 95% CI)	‐4.01 [‐8.16, 0.15]

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot	7	329	Mean Difference (IV, Random, 95% CI)	‐3.79 [‐6.88, ‐0.70]

3 CPAP X SMC Show forest plot	7	300	Mean Difference (IV, Random, 95% CI)	‐4.45 [‐10.81, 1.92]

4 CPAP X SMC ‐ heterogeneity analysis Show forest plot	5	191	Mean Difference (IV, Random, 95% CI)	‐4.10 [‐8.93, 0.72]

5 BILEVEL X SMC Show forest plot	6	254	Mean Difference (IV, Random, 95% CI)	‐4.21 [‐7.77, ‐0.65]

6 CPAP X BILEVEL Show forest plot	4	182	Mean Difference (IV, Random, 95% CI)	‐0.56 [‐5.22, 4.11]

Comparison 9. Heart rate after one hour

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Comparison 10. Sistolic blood pressure after one hour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	6	182	Mean Difference (IV, Random, 95% CI)	‐1.64 [‐7.83, 4.56]

2 CPAP X SMC Show forest plot	6	211	Mean Difference (IV, Random, 95% CI)	0.12 [‐6.56, 6.81]

3 BILEVEL X SMC Show forest plot	4	87	Mean Difference (IV, Random, 95% CI)	1.93 [‐7.94, 11.80]

4 CPAP X BILEVEL Show forest plot	4	182	Mean Difference (IV, Random, 95% CI)	‐1.17 [‐10.79, 8.44]

5 CPAP X BILEVEL ‐ heterogeneity analysis Show forest plot	3	136	Mean Difference (IV, Random, 95% CI)	2.57 [‐4.30, 9.44]

Comparison 10. Sistolic blood pressure after one hour

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Comparison 11. Diastolic blood pressure after one hour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	5	138	Mean Difference (IV, Random, 95% CI)	‐1.49 [‐6.43, 3.45]

2 CPAP X SMC Show forest plot	5	167	Mean Difference (IV, Random, 95% CI)	‐0.92 [‐9.10, 7.27]

3 CPAP X SMC ‐ heterogeneity analysis Show forest plot	3	107	Mean Difference (IV, Random, 95% CI)	‐7.32 [‐12.79, ‐1.86]

4 BILEVEL X SMC Show forest plot	4	87	Mean Difference (IV, Random, 95% CI)	‐0.96 [‐6.09, 4.16]

5 CPAP X BILEVEL Show forest plot	4	182	Mean Difference (IV, Random, 95% CI)	‐2.60 [‐9.58, 4.37]

6 CPAP X BILEVEL ‐ heterogeneity analysis Show forest plot	2	62	Mean Difference (IV, Random, 95% CI)	‐7.86 [‐13.03, ‐2.70]

Comparison 11. Diastolic blood pressure after one hour

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Comparison 12. Mean blood pressure after one hour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	3	256	Mean Difference (IV, Random, 95% CI)	‐2.41 [‐8.27, 3.45]

2 CPAP X SMC Show forest plot	1	89	Mean Difference (IV, Random, 95% CI)	3.00 [‐5.31, 11.31]

3 BILEVEL X SMC Show forest plot	2	167	Mean Difference (IV, Random, 95% CI)	‐5.42 [‐11.60, 0.76]

4 CPAP X BILEVEL Show forest plot	1	80	Mean Difference (IV, Random, 95% CI)	‐4.40 [‐13.25, 4.45]

Comparison 12. Mean blood pressure after one hour

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Comparison 13. PaO2 (mmHg) after one hour

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	4	140	Mean Difference (IV, Random, 95% CI)	10.04 [1.09, 19.00]

2 CPAP X SMC Show forest plot	5	177	Mean Difference (IV, Random, 95% CI)	‐2.64 [‐25.87, 20.59]

3 CPAP X SMC ‐ heterogeneity analysis Show forest plot	3	117	Mean Difference (IV, Random, 95% CI)	‐22.09 [‐34.35, ‐9.83]

4 BILEVEL X SMC Show forest plot	3	79	Mean Difference (IV, Random, 95% CI)	4.79 [‐11.11, 20.69]

5 CPAP X BILEVEL Show forest plot	3	136	Mean Difference (IV, Random, 95% CI)	‐27.00 [‐44.75, ‐9.25]

Comparison 13. PaO2 (mmHg) after one hour

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Comparison 14. Adverse events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	15	11329	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.63, 1.16]

1.1 Skin damage	11	594	Risk Ratio (M‐H, Random, 95% CI)	6.62 [1.20, 36.55]
1.2 Pneumonia	3	232	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.05, 2.20]
1.3 Pulmonary aspiration	5	1255	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.06, 38.61]
1.4 Gastrointestinal Bleeding	3	192	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.27, 6.89]
1.5 Gastric distention	8	484	Risk Ratio (M‐H, Random, 95% CI)	13.26 [0.82, 215.12]
1.6 Vomiting	5	1229	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.46, 2.47]
1.7 Asphyxia	2	170	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.12, 72.31]
1.8 Pneumothorax	6	1474	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.08, 6.89]
1.9 Conjunctivitis	2	147	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.10 Sinusitis	2	219	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.12, 72.31]
1.11 Disconfort with mask	7	512	Risk Ratio (M‐H, Random, 95% CI)	5.39 [0.97, 30.09]
1.12 Hypotension	1	1030	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.58, 1.16]
1.13 Arrhythmia	1	1027	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.50, 1.38]
1.14 Progressive respiratory distress	2	1122	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.37, 0.89]
1.15 Cardiorespiratory arrest	3	1252	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.29, 1.26]
1.16 Neurological failure (coma)	1	90	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.01, 0.71]
1.17 Eye irritation	1	40	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.18 Stroke	1	130	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.19 Seizures	1	130	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.03]
2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000 Show forest plot	11	10703	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.63, 1.19]

2.1 Skin damage	8	492	Risk Ratio (M‐H, Random, 95% CI)	6.62 [1.20, 36.55]
2.2 Pneumonia	2	152	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.05, 2.20]
2.3 Pulmonary aspiration	2	1095	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.06, 38.61]
2.4 Gastrointestinal Bleeding	2	170	Risk Ratio (M‐H, Random, 95% CI)	2.32 [0.35, 15.42]
2.5 Gastric distention	4	302	Risk Ratio (M‐H, Random, 95% CI)	13.26 [0.82, 215.12]
2.6 Vomiting	5	1229	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.46, 2.47]
2.7 Asphyxia	1	130	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.12, 72.31]
2.8 Pneumothorax	5	1434	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.08, 6.89]
2.9 Conjunctivitis	2	147	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.10 Sinusitis	2	219	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.12, 72.31]
2.11 Disconfort with mask	7	512	Risk Ratio (M‐H, Random, 95% CI)	5.39 [0.97, 30.09]
2.12 Hypotension	1	1030	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.58, 1.16]
2.13 Arrhythmia	1	1027	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.50, 1.38]
2.14 Progressive respiratory distress	2	1122	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.37, 0.89]
2.15 Cardiorespiratory arrest	3	1252	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.29, 1.26]
2.16 Neurological failure (coma)	1	90	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.01, 0.71]
2.17 Eye irritation	1	40	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.18 Stroke	1	130	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.19 Seizures	1	130	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.03]
3 CPAP X SMC Show forest plot	10	7133	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.45, 0.87]

3.1 Skin damage	7	343	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.13, 69.52]
3.2 Pneumonia	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 Pulmonary aspiration	5	908	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 Gastrointestinal Bleeding	1	22	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.02, 7.39]
3.5 Gastric distention	7	447	Risk Ratio (M‐H, Random, 95% CI)	11.00 [0.64, 189.65]
3.6 Vomiting	3	785	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.34, 2.54]
3.7 Asphyxia	1	40	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.8 Pneumothorax	5	998	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.9 Conjunctivitis	2	147	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.10 Sinusitis	1	89	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.11 Disconfort with mask	3	265	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.12 Hypotension	1	684	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.55, 1.25]
3.13 Arrhythmia	1	682	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.28, 1.09]
3.14 Progressive respiratory distress	2	776	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.31, 0.92]
3.15 Cardiorespiratory arrest	2	777	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.18, 0.91]
3.16 Neurological failure (coma)	1	90	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.01, 0.71]
4 BILEVEL X SMC Show forest plot	8	6823	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.76, 1.46]

4.1 Skin damage	6	296	Risk Ratio (M‐H, Random, 95% CI)	7.16 [1.27, 40.50]
4.2 Nosocomial pneumonia	2	152	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.05, 2.20]
4.3 Disconfort with mask	5	274	Risk Ratio (M‐H, Random, 95% CI)	5.39 [0.97, 30.09]
4.4 Gastrointestinal bleeding	2	170	Risk Ratio (M‐H, Random, 95% CI)	2.32 [0.35, 15.42]
4.5 Gastric dilatation	2	64	Risk Ratio (M‐H, Random, 95% CI)	15.87 [0.96, 262.30]
4.6 Vomiting	5	848	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.47, 3.11]
4.7 Claustrophobia	1	130	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.12, 72.31]
4.8 Pneumothorax	2	832	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.11, 9.63]
4.9 Eye irritation	1	40	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.10 Sinusitis	1	130	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.12, 72.31]
4.11 Cardiac arrest	2	830	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.25, 3.61]
4.12 Stroke	1	130	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.13 Seizures	1	130	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.03]
4.14 Gastric aspiration	1	704	Risk Ratio (M‐H, Random, 95% CI)	3.09 [0.13, 75.50]
4.15 Hypotension	1	698	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.54, 1.23]
4.16 Arrhythmia	1	695	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.64, 1.90]
4.17 Progressive respiratory distress	1	700	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.36, 1.03]
5 CPAP X BILEVEL Show forest plot	5	7593	Risk Ratio (M‐H, Random, 95% CI)	1.18 [0.94, 1.48]

5.1 Skin damage	5	790	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.19, 2.16]
5.2 Pneumothorax	2	715	Risk Ratio (M‐H, Random, 95% CI)	2.89 [0.12, 70.63]
5.3 Pulmonary aspiration	3	796	Risk Ratio (M‐H, Random, 95% CI)	2.88 [0.12, 70.43]
5.4 Gastric distension	3	172	Risk Ratio (M‐H, Random, 95% CI)	1.49 [0.56, 4.00]
5.5 Vomiting	4	857	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.43, 2.19]
5.6 Disconfort with mask	4	735	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.53, 2.00]
5.7 Increased breathing discomfort	1	576	Risk Ratio (M‐H, Random, 95% CI)	1.42 [0.67, 3.02]
5.8 Hypotension	2	758	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.65, 1.48]
5.9 Arrhythmia	1	677	Risk Ratio (M‐H, Random, 95% CI)	2.00 [1.02, 3.92]
5.10 Progressive respiratory distress	1	679	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.64, 2.21]
5.11 Cardiorespiratory arrest	1	678	Risk Ratio (M‐H, Random, 95% CI)	1.61 [0.59, 4.38]
5.12 Pharyngeal damage	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.06, 14.69]
5.13 Cough	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.32 [0.01, 7.57]

Comparison 14. Adverse events

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Comparison 15. Hospital or 7‐day mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	21	2263	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.55, 0.94]

Comparison 15. Hospital or 7‐day mortality

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Comparison 16. Hospital or 30‐day mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	22	2387	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.60, 0.95]

Comparison 16. Hospital or 30‐day mortality

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Comparison 17. General or 7‐day ETI rate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NPPV (CPAP and BILEVEL) X SMC Show forest plot	23	2417	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.38, 0.78]

Comparison 17. General or 7‐day ETI rate

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Ventilación no invasiva con presión positiva (PPCVR o VNIPP a dos niveles) para el edema pulmonar cardiogénico

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