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Ventilación no invasiva para el tratamiento de la insuficiencia respiratoria hipercápnica aguda debida a la exacerbación de la enfermedad pulmonar obstructiva crónica

Información

DOI:
https://doi.org/10.1002/14651858.CD004104.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 13 julio 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Vías respiratorias

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Christian R Osadnik

    Correspondencia a: Department of Physiotherapy, Monash University, Melbourne, Australia

    [email protected]

    [email protected]

    Monash Lung and Sleep, Monash Health, Melbourne, Australia

    Institute for Breathing and Sleep, Melbourne, Australia

  • Vanessa S Tee

    Department of Respiratory Medicine, The Queen Elizabeth Hospital, The University of Adelaide, Adelaide, Australia

  • Kristin V Carson‐Chahhoud

    School of Medicine, The University of Adelaide, Adelaide, Australia

  • Joanna Picot

    Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK

  • Jadwiga A Wedzicha

    National Heart and Lung Institute, Imperial College London, London, UK

  • Brian J Smith

    School of Medicine, The University of Adelaide, Adelaide, Australia

Contributions of authors

CO and VT updated the latest version of the review, including protocol revision, literature screening, data extraction, data analysis, and write‐up of results. KC provided assistance with all of these activities. JP and JW contributed to the previous publication of this review (April 2004) and assisted in protocol design and review of the draft for the latest version of the review. Felix SF Ram, Josephine Lightowler, and JW completed the original review.

Sources of support

Internal sources

  • Respiratory Medicine Department, The Queen Elizabeth Hospital, Australia.

External sources

  • The authors declare that no such funding was received for this systematic review, Other.

Declarations of interest

CO: none known.

VT: none known.

KC: none known.

JP: none known.

JW: none known.

BS: none known.

Acknowledgements

We would like to acknowledge all authors involved in earlier versions of this Cochrane review (Felix SF Ram, Josephine Lightowler, and Jadwiga Wedzicha) for their substantial contributions to the text and content of this review. We wish to thank authors of studies who responded to requests for clarification or further data regarding their trials (Avdeev 1998; Bott 1993; Khilnani 2010; Kramer 1995; Plant 2001; Thys 2002). We would like to thank the following colleagues for providing assistance with data extraction and translation of articles published in languages other than English: Alieksei Seniukovich, Yi Liu, Claudio Bravo, Petra Kristyna Matejkova, Hong Fan, Zongwang Zhang, and Jan Strojil.

Rebecca Normansell was the Editor for this review and commented critically on the review.

The Methods sections of this review were based on a standard template used by the Cochrane Airways Review Group.

This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to the Cochrane Airways Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS, or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2017 Jul 13

Non‐invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease

Review

Christian R Osadnik, Vanessa S Tee, Kristin V Carson‐Chahhoud, Joanna Picot, Jadwiga A Wedzicha, Brian J Smith

https://doi.org/10.1002/14651858.CD004104.pub4

2004 Jul 19

Non‐invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease

Review

Felix SF Ram, Joanna Picot, Josephine Lightowler, Jadwiga A Wedzicha

https://doi.org/10.1002/14651858.CD004104.pub3

2003 Oct 20

Non‐invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease

Review

Felix S F Ram, Joanna Picot, J Lightowler, J A Wedzicha

https://doi.org/10.1002/14651858.CD004104.pub2

Differences between protocol and review

Updates undertaken since publication of the original review resulted in the following changes to the protocol.

  1. Significant updates to the methods to bring the review in line with current Cochrane (MECIR) standards. This included insertion of a 'Summary of findings' table and updates to the risk of bias methods (removal of the Jadad scale). This process included evaluation of the following additional domains of potential bias: imbalance of outcome measures at baseline, comparability of intervention and control group characteristics at baseline, protection against contamination, and selective recruitment of participants.

  2. Following critical feedback regarding this review, we amended the definition of AHRF from the initial review to now include reference to pH < 7.35. We deemed this essential to enhance its consistency with clinical practice.

  3. Amendment of primary review outcomes. In the initial version, the primary outcome was 'treatment failure', defined according to any combination of intubation, mortality, or treatment failure. To remove ambiguity regarding overlap between these definitions, the current version lists treatment intolerance as an independent secondary review outcome. We also made clarifications to the definition of our primary outcome 'need for endotracheal intubation' to minimise ambiguity.

  4. Exclusion of one study that was included in the original review (Conti 2002) due to inclusion of mechanical ventilation as a comparator intervention; and reclassification of one study originally included in the review (Servillo 1994) to 'Awaiting classification' due to lack of sufficient information pertaining to mean baseline pH to determine eligibility for inclusion in the review in accordance with our revised definition of AHRF.

  5. Replacement of one abstract included in the original review with a full‐text version in the update (Khilnani 2002 is now Khilnani 2010).

  6. Minor edits to wording of two eligibility criteria to explicitly clarify that (a) studies of patients who commenced NIV before hospital admission are ineligible for inclusion in the review; and (b) 'usual medical care' may not include any form of positive pressure ventilation considered to be 'usual' for that study centre.

  7. Thys 2002 was originally included as an 'ICU' study in the subgroup analysis of ward versus ICU care. As this study was based in an emergency department (potentially more intensive than a ward, but not an ICU setting), in keeping with the primary aim of the review, we excluded this study from the ward versus ICU subgroup analysis for the present (and subsequent) updates.

  8. Data from Bott 1993 were originally included in some of the meta‐analyses related to blood gas tensions; however owing to lack of sufficient study information regarding the number of participants included in these outcome data, this study was subsequently removed from the meta‐analysis and was reported separately. Additionally, mortality data were removed from the meta‐analysis, as they were identified as relevant to the post‐discharge period, not to in‐hospital mortality.

  9. We conducted subgroup analyses of admission pH and location only for the primary outcomes of interest for this review (mortality and need for endotracheal intubation), rather than for all outcomes.

  10. One additional table (percentage change in PaCO2 at one hour post intervention) included in the earlier review was removed.

  11. Type of NIV for subgroup analysis was removed from the investigation of heterogeneity section of the protocol, as all studies except one used pressure‐cycled NIV.

Keywords

MeSH

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.

Study flow diagram for 2004‐2017 literature searches.
Figuras y tablas -
Figure 1

Study flow diagram for 2004‐2017 literature searches.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

NIV vs usual care (overall) ‐ Mortality
Figuras y tablas -
Figure 3

NIV vs usual care (overall) ‐ Mortality

Cates plot Analysis 1.1 (mortality), NIV group: In the usual care group, 18 of 100 people died during the period of hospitalisation, compared with 10 (95% CI 7 to 14) of 100 in the NIV group.
Figuras y tablas -
Figure 4

Cates plot Analysis 1.1 (mortality), NIV group: In the usual care group, 18 of 100 people died during the period of hospitalisation, compared with 10 (95% CI 7 to 14) of 100 in the NIV group.

Funnel plot of comparison: 1 NIV vs usual care ‐ Overall, outcome: 1.1 Mortality.
Figuras y tablas -
Figure 5

Funnel plot of comparison: 1 NIV vs usual care ‐ Overall, outcome: 1.1 Mortality.

NIV vs usual care (overall) ‐ Need for endotracheal intubation
Figuras y tablas -
Figure 6

NIV vs usual care (overall) ‐ Need for endotracheal intubation

Cates plot Analysis 1.2 (need for endotracheal intubation), NIV group: In the usual care group, 34 of 100 people experienced the need for endotracheal intubation during the period of hospitalisation, compared with 12 (95% CI 10 to 16) of 100 in the NIV group.
Figuras y tablas -
Figure 7

Cates plot Analysis 1.2 (need for endotracheal intubation), NIV group: In the usual care group, 34 of 100 people experienced the need for endotracheal intubation during the period of hospitalisation, compared with 12 (95% CI 10 to 16) of 100 in the NIV group.

Funnel plot of comparison: 1 NIV vs usual care ‐ Overall, outcome: 1.2 Need for endotracheal intubation.
Figuras y tablas -
Figure 8

Funnel plot of comparison: 1 NIV vs usual care ‐ Overall, outcome: 1.2 Need for endotracheal intubation.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 NIV vs usual care ‐ Overall, Outcome 1 Mortality.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 2 Need for endotracheal intubation.
Figuras y tablas -
Analysis 1.2

Comparison 1 NIV vs usual care ‐ Overall, Outcome 2 Need for endotracheal intubation.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 3 Length of hospital stay (days).
Figuras y tablas -
Analysis 1.3

Comparison 1 NIV vs usual care ‐ Overall, Outcome 3 Length of hospital stay (days).

Comparison 1 NIV vs usual care ‐ Overall, Outcome 4 Length of ICU stay (days).
Figuras y tablas -
Analysis 1.4

Comparison 1 NIV vs usual care ‐ Overall, Outcome 4 Length of ICU stay (days).

Comparison 1 NIV vs usual care ‐ Overall, Outcome 5 Symptom scores (higher score means more dyspnoea).
Figuras y tablas -
Analysis 1.5

Comparison 1 NIV vs usual care ‐ Overall, Outcome 5 Symptom scores (higher score means more dyspnoea).

Comparison 1 NIV vs usual care ‐ Overall, Outcome 6 Treatment intolerance.
Figuras y tablas -
Analysis 1.6

Comparison 1 NIV vs usual care ‐ Overall, Outcome 6 Treatment intolerance.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 7 Complications of treatment.
Figuras y tablas -
Analysis 1.7

Comparison 1 NIV vs usual care ‐ Overall, Outcome 7 Complications of treatment.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 8 pH 1 hour post intervention.
Figuras y tablas -
Analysis 1.8

Comparison 1 NIV vs usual care ‐ Overall, Outcome 8 pH 1 hour post intervention.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 9 PaCO2 mmHg ‐ 1 hour post intervention.
Figuras y tablas -
Analysis 1.9

Comparison 1 NIV vs usual care ‐ Overall, Outcome 9 PaCO2 mmHg ‐ 1 hour post intervention.

Comparison 1 NIV vs usual care ‐ Overall, Outcome 10 PaO2 mmHg ‐ 1 hour post intervention.
Figuras y tablas -
Analysis 1.10

Comparison 1 NIV vs usual care ‐ Overall, Outcome 10 PaO2 mmHg ‐ 1 hour post intervention.

Comparison 2 NIV vs UMC ‐ Admission pH subgroups, Outcome 1 Mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 NIV vs UMC ‐ Admission pH subgroups, Outcome 1 Mortality.

Comparison 2 NIV vs UMC ‐ Admission pH subgroups, Outcome 2 Need for endotracheal intubation.
Figuras y tablas -
Analysis 2.2

Comparison 2 NIV vs UMC ‐ Admission pH subgroups, Outcome 2 Need for endotracheal intubation.

Comparison 3 NIV vs UMC ‐ Trial location subgroups, Outcome 1 Mortality.
Figuras y tablas -
Analysis 3.1

Comparison 3 NIV vs UMC ‐ Trial location subgroups, Outcome 1 Mortality.

Comparison 3 NIV vs UMC ‐ Trial location subgroups, Outcome 2 Need for endotracheal intubation.
Figuras y tablas -
Analysis 3.2

Comparison 3 NIV vs UMC ‐ Trial location subgroups, Outcome 2 Need for endotracheal intubation.

Summary of findings for the main comparison. Non‐invasive ventilation versus usual medical care for management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease (overall effects)

Non‐invasive ventilation versus usual medical care for management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease (overall effects)

Patient or population: Patients admitted to hospital with acute hypercapnic respiratory failure due to an exacerbation of chronic obstructive pulmonary disease (COPD)
Setting: Acute inpatient
Intervention: Non‐invasive ventilation
Comparison: Usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with usual care ‐ Overall

Risk with NIV

Mortality

183 per 1000

99 per 1000
(70 to 139)

RR 0.54
(0.38 to 0.76)

854
(12 RCTs)

⊕⊕⊕⊝
MODERATEa

Downgraded owing to risk of bias for some included studies

Need for endotracheal intubation

341 per 1000

123 per 1000
(95 to 157)

RR 0.36
(0.28 to 0.46)

1105
(17 RCTs)

⊕⊕⊕⊝
MODERATEa

Downgraded owing to risk of bias for some included studies

Length of hospital stay (days)

Mean length of hospital stay (days) was 17.5

MD 3.39 lower
(5.93 lower to 0.85 lower)

888
(10 RCTs)

⊕⊕⊕⊝
MODERATEa,b

Downgraded owing to risk of bias and inconsistency of findings for some included studies

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)

CI: confidence interval; OR: odds ratio; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

aSeveral risk of bias items rated 'unclear'

bOne study reported an effect estimate that favoured usual medical care (non‐significant); significant statistical heterogeneity identified within the intensive care unit subgroup was unable to be resolved

Figuras y tablas -
Summary of findings for the main comparison. Non‐invasive ventilation versus usual medical care for management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease (overall effects)
Comparison 1. NIV vs usual care ‐ Overall

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

12

854

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.38, 0.76]

2 Need for endotracheal intubation Show forest plot

17

1105

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.28, 0.46]

3 Length of hospital stay (days) Show forest plot

10

888

Mean Difference (IV, Random, 95% CI)

‐3.39 [‐5.93, ‐0.85]

4 Length of ICU stay (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Symptom scores (higher score means more dyspnoea) Show forest plot

4

484

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.16 [‐0.34, 0.02]

5.1 Borg score

2

82

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.35 [‐0.79, 0.08]

5.2 Visual analogue scale

1

60

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.87 [‐1.40, ‐0.34]

5.3 Dyspnoea score at 24 hours

1

342

Std. Mean Difference (IV, Fixed, 95% CI)

0.0 [‐0.21, 0.21]

6 Treatment intolerance Show forest plot

6

252

Risk Difference (M‐H, Fixed, 95% CI)

0.11 [0.04, 0.17]

7 Complications of treatment Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7.1 NIV related

6

567

Risk Ratio (M‐H, Fixed, 95% CI)

29.60 [9.47, 92.51]

7.2 Non‐NIV related

2

125

Risk Ratio (M‐H, Fixed, 95% CI)

0.26 [0.13, 0.53]

8 pH 1 hour post intervention Show forest plot

8

585

Mean Difference (IV, Random, 95% CI)

0.05 [0.02, 0.07]

9 PaCO2 mmHg ‐ 1 hour post intervention Show forest plot

8

585

Mean Difference (IV, Random, 95% CI)

‐4.62 [‐11.05, 1.80]

10 PaO2 mmHg ‐ 1 hour post intervention Show forest plot

8

585

Mean Difference (IV, Random, 95% CI)

7.47 [0.78, 14.16]

Figuras y tablas -
Comparison 1. NIV vs usual care ‐ Overall
Comparison 2. NIV vs UMC ‐ Admission pH subgroups

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

12

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Admission pH > 7.30

5

454

Risk Ratio (M‐H, Fixed, 95% CI)

0.50 [0.30, 0.84]

1.2 Admission pH < 7.30

8

400

Risk Ratio (M‐H, Fixed, 95% CI)

0.57 [0.35, 0.90]

2 Need for endotracheal intubation Show forest plot

17

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Admission pH > 7.30

7

589

Risk Ratio (M‐H, Fixed, 95% CI)

0.44 [0.30, 0.63]

2.2 Admission pH < 7.30

11

516

Risk Ratio (M‐H, Fixed, 95% CI)

0.31 [0.22, 0.42]

Figuras y tablas -
Comparison 2. NIV vs UMC ‐ Admission pH subgroups
Comparison 3. NIV vs UMC ‐ Trial location subgroups

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

10

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Intensive care unit

5

251

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.34, 1.07]

1.2 Ward

5

543

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.29, 0.78]

2 Need for endotracheal intubation Show forest plot

16

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Intensive care unit

9

401

Risk Ratio (M‐H, Fixed, 95% CI)

0.30 [0.21, 0.43]

2.2 Ward

8

721

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.31, 0.60]

Figuras y tablas -
Comparison 3. NIV vs UMC ‐ Trial location subgroups