ProSeal versus vía aérea por mascarilla laríngea clásica (VML) para la asistencia respiratoria con presión positiva en adultos sometidos a una cirugía electiva
Información
- DOI:
- https://doi.org/10.1002/14651858.CD009026.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 20 julio 2017see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Anestesia
- Copyright:
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- Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Citado por:
Autores
Contributions of authors
Muhammad Qamarul Hoda (QH), Khalid Samad (KS), Hameed Ullah (HU).
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Conceiving the review: QH.
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Co‐ordinating the review: QH.
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Undertaking manual searches: QH, KS.
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Screening search results: QH, KS.
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Organizing retrieval of papers: QH, KS.
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Screening retrieved papers against inclusion criteria: QH, KS, HU.
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Appraising quality of papers: HU.
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Abstracting data from papers: QH, KS.
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Writing to authors of papers for additional information: QH.
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Providing additional data about papers: KS.
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Obtaining and screening data on unpublished studies: QH.
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Managing data for the review: HU, KS.
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Entering data into Review Manager (RevMan 5.3): KS.
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Analysing RevMan statistical data: HU, KS.
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Conducting other statistical analysis not using RevMan: HU, KS.
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Performing double entry of data: data entered by person one: KS; data entered by person two: QH.
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Interpreting data: QH, HU.
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Making statistical inferences: HU.
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Writing the review: QH.
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Securing funding for the review: QH (if required).
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Performing previous work that was the foundation of the present study: KS, HU.
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Serving as guarantor for the review (one author) QH.
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Taking responsibility for reading and checking the review before submission: HU.
Sources of support
Internal sources
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Resources for this review were provided by Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan.
External sources
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No sources of support supplied
Declarations of interest
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Muhammad Qamarul Hoda: none known.
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Khalid Samad: none known.
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Hameed Ullah: none known.
Acknowledgements
We would like to thank Mike Bennett (Contact Editor); Nathan Pace (Statistical Editor); Tim M Cook and Subrahmanyn Radhakrishna (Peer Referees); and Janet Wale (Consumer Referee) for help and editorial advice provided during preparation of this systematic review. We also would like to thank Karen Hovhannisyan (former Trials Search Co‐ordinator, Cochrane Anaesthesia, Critical and Emergency Care Group (ACE)) for developing and running the search strategies and for helping us obtain full‐text copies of papers; Ann Jones for copyediting the review; and Jane Cracknell (Managing Editor, ACE) for co‐ordinating the review.
We would like to thank and acknowledge Mike Bennett (Contact Editor); Nathan Pace (Statistical Editor); and Georgie Imberger and Mark Hamilton (Peer Referees) for help and editorial advice provided during preparation of the protocol (Qamarul Hoda 2011).
We would also like to thank Mr Syed Amir Raza, Department of Anaesthesiology, Aga Khan University, for statistical assistance.
Version history
| Published | Title | Stage | Authors | Version |
| 2017 Jul 20 | ProSeal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adults undergoing elective surgery | Review | Muhammad Qamarul Hoda, Khalid Samad, Hameed Ullah | |
| 2011 Mar 16 | ProSeal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adult patients undergoing elective surgery | Protocol | Muhammad Qamarul Hoda, Khalid Samad, Hameed Ullah | |
Differences between protocol and review
We made the following changes to the review (Qamarul Hoda 2011).
Additional searches
We added two search engines (ISI Web of Science (1946 to November 2016) and CINAHL (EBSCO host, 1982 to November 2016)) to ensure wider coverage of the evidence.
Types of studies
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We planned to include randomized controlled trials (RCTs) and quasi‐RCTs comparing the effectiveness of positive pressure ventilation with Classic and ProSeal LMAs in adults undergoing elective surgery. In the review, we included only RCTs because we found no quasi‐RCTs in our searches.
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We planned to include only data related to the device used first for cross‐over studies. In the review, we have placed cross‐over studies under “Studies awaiting classification” because we have written to the authors of the four cross‐over studies regarding data and are awaiting their responses.
Primary outcome
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Following a suggestion from a peer referee, we subdivided the primary outcome ‐ failure to adequately mechanically ventilate ‐ to include two variables: inadequate oxygenation and inadequate ventilation. We considered all other variables as secondary outcomes.
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We had planned to assess oxygenation according to peripheral oxygen saturation (SpO₂) or partial pressure of oxygen in arterial blood (PaO₂). We assessed ventilation according to end‐tidal carbon dioxide concentration (ETCO₂) or partial CO₂ pressure in arterial blood (PaCO₂).
We evaluated the primary outcome ‐ failure to adequately mechanically ventilate ‐ according to:
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inadequate oxygenation ‐ < 90% on peripheral oxygen saturation (SaO₂); or
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inadequate ventilation ‐ ETCO₂ > 45 mm Hg.
Secondary outcomes
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We did not include "effective airway time" and "failure to insert gastric tube" as outcomes in the protocol (Qamarul Hoda 2011). We added these post hoc because some included studies looked at this outcome.
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After wide consultation, we amended secondary outcomes in the protocol to include the following.
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Inability to insert or abandon intended device ‐ as assessed by inability to insert and/or use of alternate device.
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Effective airway time ‐ as assessed by time taken to insert and adequately ventilate with either device.
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Failure to insert gastric tube.
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Peak airway pressure during positive pressure ventilation.
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Oropharyngeal leak pressure.
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Complications related to insertion of the LMA: mucosal injury (blood staining), sore throat, excessive leak, gastric insufflation, bronchospasm/laryngospasm, regurgitation/aspiration, coughing, obstruction of device, excessive secretions, and postoperative nausea or vomiting.
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Any other.
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These were formerly the following.
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Complications related to use of LMA including laryngospasm, coughing, bronchospasm, aspiration or obstruction, sore throat, and mucosal injury (blood staining).
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Peak airway pressure during positive pressure ventilation.
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Oropharyngeal leak pressure (seal pressure).
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Gastric insufflation.
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Regurgitation or pulmonary aspiration, or both.
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Postoperative nausea or vomiting (PONV).
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Any other.
Summary of findings table
In protocol, we planned to present the following outcomes in the SoF table:
1. Failure to adequately mechanically ventilate
2. Airway complications
3. Insertion attempts
4. Aspiration
5. Gastric insufflation
6. Peak airway pressure
7. Oropharyngeal leak pressure (Seal Pressure)
However, based on the reason mentioned above in primary outcome section, " failure to adequately mechanically ventilate" has been modified to " inadequate oxygenation" and " inadequate ventilation".
Outcomes "airway complications (except sore throat), insertion attempts, aspiration, and gastric insufflation" have not been presented in SoF table as all of these were either uncertain or insignificant.
We identified "effective airway time" and "regurgitation" as outcomes assesed by some of our included studies so we added this in SoF.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Adult; Humans;
PICO
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Failure to mechanically ventilate, Outcome 1 Inadequate oxygenation.
Comparison 2 Failure to insert or use of alternate device, Outcome 1 Failure to insert or use of alternate device.
Comparison 3 Effective airway time (seconds), Outcome 1 Effective airway time (seconds).
Comparison 4 Peak airway pressure during positive pressure ventilation, Outcome 1 Peak airway pressure during positive pressure ventilation.
Comparison 5 Oropharyngeal leak pressure (seal pressure), Outcome 1 Oropharyngeal leak pressure (seal pressure) (cm H₂O).
Comparison 6 Complications, Outcome 1 Mucosal injury.
Comparison 6 Complications, Outcome 2 Sore throat.
Comparison 6 Complications, Outcome 3 Bronchospasm.
Comparison 6 Complications, Outcome 4 Gastric insufflation.
Comparison 6 Complications, Outcome 5 Regurgitation.
Comparison 6 Complications, Outcome 6 Coughing.
Comparison 6 Complications, Outcome 7 Excessive leak.
| ProSeal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adult patients undergoing elective surgery | ||||||
| Patient or population: adult patients (18 years of age and older) for positive pressure ventilation undergoing elective surgery Comparison: Classic laryngeal mask airway (cLMA) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants (studies) | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| cLMA | pLMA | |||||
| Inadequate oxygenation (SaO₂ < 90% on peripheral oxygen saturation) | 13 per 1000 | 10 per 1000 (2 to 43) | RR 0.75 (0.17 to 3.31) | 617 (4 studies) | ⊕⊝⊝⊝ | |
| Inadequate ventilation ( ETCO₂ > 45 mm Hg) | See comment | See comment | Not estimable | 80 | See comment | No episodes of inadequate ventilation in either group |
| Time required for effective airway (seconds) | Mean effective airway time in the control group ranged from 22.24 seconds to 31 seconds | Mean effective airway time in the intervention group was 10.12 seconds longer (95% CI 5.04 to 15.21) | 434 | ⊕⊕⊝⊝ Lowb | Outcome added post protocol as some included studies looked at this outcome. | |
| Peak airway pressure during positive pressure ventilation (cm H₂O) | Peak airway pressure in the control group ranged from 17 cm H₂O to 24.5 cm H₂O | Mean peak airway pressure during positive pressure ventilation was higher in the pLMA group by 0.84 cm H₂O (95% CI 0.02 to 1.67) | 259 (4) | ⊕⊕⊝⊝ Lowc | ||
| Oropharyngeal leak pressure (seal pressure) (cm H₂O) | Oropharyngeal leak pressure in the control group ranged from 14.64 cm H₂O to 26 cm H₂O | Mean oropharyngeal leak pressure (seal pressure) was higher in the pLMA group by 7.17 cm H₂O (95% CI 4.85 to 9.5) | 709 | ⊕⊕⊝⊝ | ||
| Sore throat | 194 per 1000 | 150 per 1000 (107 to 210) | RR 0.77 (0.55 to 1.08) | 653 (5) | ⊕⊕⊝⊝ Lowe | |
| Regurgitation | 17 per 1000 | 13 per 1000 (4 to 45) | RR 0.8 (0.24 to 2.69) | 597 (4) | ⊕⊕⊝⊝ Lowf | |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (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). | ||||||
| GRADE Working Group grades of evidence. | ||||||
| aThree studies reporting this outcome were assessed as demonstrating adequate allocation concealment and one was unclear. Blinding of participants, personnel and outcome assessor were assessed as unclear in three studies and one study was unblinded. Furthermore, the results are imprecise, as only one out of four studies has reported positive events, therefore evidence is downgraded three levels. bData from two studies with imprecise results resulted in downgrading of evidence by two levels. cBlinding of participants, personnel and outcome assessors were unclear in three studies and one study was unblinded. This resulted in downgrading the evidence by two levels. dBlinding of participant and personnel were unclear in all six studies while blinding of outcome assessor was not conducted in one study and was unclear in the remaining five studies. Data analysis indicated high levels of heterogeneity (inconsistency). For these reasons, the evidence was downgraded two levels. eBlinding of participant and personnel were unclear in four studies and was not done in one study, while blinding of outcome assessor was not conducted in two studies and was unclear in the remaining three studies. This resulted in downgrading the evidence by two levels. fBlinding of participant and personnel were unclear in all four studies while blinding of outcome assessor was not conducted in one study and was unclear in the remaining three studies, therefore evidence was downgraded two levels. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Inadequate oxygenation Show forest plot | 4 | 617 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.75 [0.17, 3.31] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Failure to insert or use of alternate device Show forest plot | 7 | 769 | Risk Ratio (M‐H, Fixed, 95% CI) | 2.2 [0.50, 9.72] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Effective airway time (seconds) Show forest plot | 2 | 434 | Mean Difference (IV, Fixed, 95% CI) | 10.12 [5.04, 15.21] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Peak airway pressure during positive pressure ventilation Show forest plot | 4 | 259 | Mean Difference (IV, Fixed, 95% CI) | 0.84 [0.02, 1.67] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Oropharyngeal leak pressure (seal pressure) (cm H₂O) Show forest plot | 6 | 709 | Mean Difference (IV, Random, 95% CI) | 6.93 [4.23, 9.62] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Mucosal injury Show forest plot | 4 | 617 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.49 [0.97, 2.28] |
| 2 Sore throat Show forest plot | 5 | 653 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.77 [0.55, 1.08] |
| 3 Bronchospasm Show forest plot | 3 | 537 | Risk Ratio (M‐H, Fixed, 95% CI) | 3.0 [0.12, 73.19] |
| 4 Gastric insufflation Show forest plot | 2 | 487 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.03, 3.18] |
| 5 Regurgitation Show forest plot | 4 | 597 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.8 [0.24, 2.69] |
| 6 Coughing Show forest plot | 2 | 444 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.72 [0.36, 1.43] |
| 7 Excessive leak Show forest plot | 2 | 120 | Risk Ratio (M‐H, Fixed, 95% CI) | 3.0 [0.13, 70.83] |
