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Cochrane Database of Systematic Reviews

喉罩通气与袋式面罩通气或气管插管用于新生儿复苏

Information

DOI:
https://doi.org/10.1002/14651858.CD003314.pub3Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 15 March 2018see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Neonatal Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Mosarrat J Qureshi

    Correspondence to: Northern Alberta Neonatal Program, Royal Alexandra Hospital, Edmonton, Canada

    [email protected]

  • Manoj Kumar

    Department of Pediatrics, University of Alberta, Edmonton, Canada

Contributions of authors

Both authors (MQ and MK) searched literature, reviewed studies, co‐authored text, entered data and checked data entry for accuracy.

Declarations of interest

None

Acknowledgements

The authors are grateful to Ms Liz Dennett (Librarian, John W Scott Health Sciences Library at the University of Alberta in Edmonton) for providing assistance with the literature search for this review.

We would like to acknowledge the original review authors, Andrew J. Grein, Gary M Weiner (Grein 2001, Grein 2005).

Version history

Published

Title

Stage

Authors

Version

2018 Mar 15

Laryngeal mask airway versus bag‐mask ventilation or endotracheal intubation for neonatal resuscitation

Review

Mosarrat J Qureshi, Manoj Kumar

https://doi.org/10.1002/14651858.CD003314.pub3

2005 Apr 20

Laryngeal mask airway versus bag‐mask ventilation or endotracheal intubation for neonatal resuscitation

Review

Andrew J. Grein, Gary M Weiner

https://doi.org/10.1002/14651858.CD003314.pub2

2001 Jul 23

Laryngeal mask airway versus bag‐mask ventilation or endotracheal intubation for neonatal resuscitation

Protocol

Andrew J. Grein, Gary M Weiner

https://doi.org/10.1002/14651858.CD003314

Differences between protocol and review

We made changes to outcomes presented in the previous version of this review after extensive discussion among review authors with the aim of making the review more meaningful in terms of clinical practice.

Additional searches:

We have added another search engine (EMBASE) to ensure wider coverage of the evidence.

Primary outcomes:

Our search identified studies comparing LMA to BMV, which were not available at the time of the previous version of this review. Also the newly identified studies reported additional outcomes. As such we amended the primary outcomes according to clinical significance. We included:

  1. Need for endotracheal intubation (LMA vs. BMV studies only).

  2. Failure with primary modality of resuscitation (LMA vs. BMV studies only)

  3. Ventilation time (Time from birth, or from the beginning of intervention, until the discontinuation of positive pressure ventilation as part of resuscitation).

  4. Time to spontaneous breathing (or described as time to definitive response following the onset of intervention).

  5. Admission to NICU

  6. Death or hypoxic Ischemic encephalopathy (HIE) in the delivery room.

Secondary outcomes:

After discussion, we amended secondary outcomes in this review to include the following:

  1. Time until heart rate greater than 100 beats/minute.

  2. Apgar score less than or equal to 7 at 5 minutes

  3. Apgar scores at 5 and 10 minutes

  4. Frequency of post‐resuscitation oral, airway, or facial trauma, or any other procedural related complication

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram: LMA versus BMV or endotracheal intubation for neonatal resuscitation review update
Figures and Tables -
Figure 1

Study flow diagram: LMA versus BMV or endotracheal intubation for neonatal resuscitation review update

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

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

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

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

Comparison 1 LMA versus BMV, Outcome 1 Failure with primary modality of resuscitation.
Figures and Tables -
Analysis 1.1

Comparison 1 LMA versus BMV, Outcome 1 Failure with primary modality of resuscitation.

Comparison 1 LMA versus BMV, Outcome 2 Need for intubation.
Figures and Tables -
Analysis 1.2

Comparison 1 LMA versus BMV, Outcome 2 Need for intubation.

Comparison 1 LMA versus BMV, Outcome 3 Time to spontaneous breathing.
Figures and Tables -
Analysis 1.3

Comparison 1 LMA versus BMV, Outcome 3 Time to spontaneous breathing.

Comparison 1 LMA versus BMV, Outcome 4 Ventilation time [seconds].
Figures and Tables -
Analysis 1.4

Comparison 1 LMA versus BMV, Outcome 4 Ventilation time [seconds].

Comparison 1 LMA versus BMV, Outcome 5 Apgar score ≤ 7 at 5 min.
Figures and Tables -
Analysis 1.5

Comparison 1 LMA versus BMV, Outcome 5 Apgar score ≤ 7 at 5 min.

Comparison 1 LMA versus BMV, Outcome 6 Admission to NICU.
Figures and Tables -
Analysis 1.6

Comparison 1 LMA versus BMV, Outcome 6 Admission to NICU.

Comparison 1 LMA versus BMV, Outcome 7 Death or HIE.
Figures and Tables -
Analysis 1.7

Comparison 1 LMA versus BMV, Outcome 7 Death or HIE.

Comparison 2 LMA versus endotracheal intubation, Outcome 1 Failure to correctly insert the device.
Figures and Tables -
Analysis 2.1

Comparison 2 LMA versus endotracheal intubation, Outcome 1 Failure to correctly insert the device.

Comparison 2 LMA versus endotracheal intubation, Outcome 2 Successful insertion of device at first attempt.
Figures and Tables -
Analysis 2.2

Comparison 2 LMA versus endotracheal intubation, Outcome 2 Successful insertion of device at first attempt.

Comparison 2 LMA versus endotracheal intubation, Outcome 3 Insertion time.
Figures and Tables -
Analysis 2.3

Comparison 2 LMA versus endotracheal intubation, Outcome 3 Insertion time.

Comparison 2 LMA versus endotracheal intubation, Outcome 4 Ventilation time [seconds].
Figures and Tables -
Analysis 2.4

Comparison 2 LMA versus endotracheal intubation, Outcome 4 Ventilation time [seconds].

Comparison 2 LMA versus endotracheal intubation, Outcome 5 Apgar score ≤7 at 5 minutes.
Figures and Tables -
Analysis 2.5

Comparison 2 LMA versus endotracheal intubation, Outcome 5 Apgar score ≤7 at 5 minutes.

Comparison 2 LMA versus endotracheal intubation, Outcome 6 Soft tissue trauma after device inserted.
Figures and Tables -
Analysis 2.6

Comparison 2 LMA versus endotracheal intubation, Outcome 6 Soft tissue trauma after device inserted.

Comparison 2 LMA versus endotracheal intubation, Outcome 7 Death or HIE.
Figures and Tables -
Analysis 2.7

Comparison 2 LMA versus endotracheal intubation, Outcome 7 Death or HIE.

Summary of findings for the main comparison. LMA compared to BMV for neonatal resuscitation

LMA compared to BMV for neonatal resuscitation

Patient or population: neonatal resuscitation
Setting:
Intervention: LMA
Comparison: BMV

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with BMV

Risk with LMA

Failure with primary modality of resuscitation

Study population

RR 0.16
(0.09 to 0.30)

660
(5 RCTs)

⊕⊕⊕⊝
MODERATE 1

194 per 1000

31 per 1000
(17 to 58)

Need for intubation

Study population

RR 0.24
(0.12 to 0.47)

660
(5 RCTs)

⊕⊕⊕⊝
MODERATE 1

158 per 1000

38 per 1000
(19 to 74)

Apgar score ≤ 7 at 5 minutes

Study population

RR 0.34
(0.16 to 0.74)

511
(2 RCTs)

⊕⊕⊕⊝
MODERATE2

94 per 1000

32 per 1000
(15 to 69)

Admission to NICU

Study population

RR 0.6
(0.4 to 0.9)

191
(2 RCTs)

⊕⊕⊕⊝
MODERATE3

438 per 1000

263 per 1000
(175 to 394)

Death or HIE

Study population

RR 0.65
(0.17 to 2.43)

191
(2 RCTs)

⊕⊕⊝⊝
LOW3 4

52 per 1000

34 per 1000
(9 to 127)

*The risk in the intervention group (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).
Apgar: A=Activity, P=Pulse, G=Grimace, A=Appearance, R= Respiration; BMV: Bag mask Ventilation; HIE: Hypoxic Ischemic Encephalopathy; LMA: laryngeal mask airway; NICU: Neonatal Intensive Care Unit; RCT: Randomised controlled Trial; CI: confidence interval; RR: risk ratio; OR: odds ratio;

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Downgraded one level for serious study limitations (The largest of the included studies was a quasi‐randomised trial)

2 Downgraded one level for serious study limitations (One of the 2 studies was a quasi‐randomised trial)

3 Downgraded two levels due to high risk of performance bias and detection bias in both studies

4 Downgraded two levels due to moderate degree of heterogeneity (I2= 46%)

Figures and Tables -
Summary of findings for the main comparison. LMA compared to BMV for neonatal resuscitation
Summary of findings 2. LMA compared to endotracheal intubation for neonatal resuscitation

LMA compared to endotracheal intubation for neonatal resuscitation

Patient or population: neonatal resuscitation
Setting:
Intervention: LMA
Comparison: endotracheal intubation

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with endotracheal intubation

Risk with LMA

Failure to correctly insert the device

Study population

RR 0.95
(0.17 to 5.42)

158
(3 RCTs)

⊕⊝⊝⊝
VERY LOW1

26 per 1000

25 per 1000
(4 to 141)

Successful insertion of device at first attempt

Study population

RR 1.01
(0.89 to 1.14)

108
(2 RCTs)

⊕⊝⊝⊝
VERY LOW2

904 per 1000

913 per 1000
(804 to 1000)

Apgar score ≤ 7 at 5 minutes

Study population

RR 0.70
(0.34 to 1.45)

108
(2 RCTs)

⊕⊕⊝⊝
LOW3

250 per 1000

175 per 1000
(85 to 363)

Soft tissue trauma after device inserted

Study population

RR 2.00
(0.58 to 6.91)

40
(1 RCT)

⊕⊕⊝⊝
LOW4

150 per 1000

300 per 1000
(87 to 1000)

Death or HIE

Study population

RR 0.59
(0.11 to 3.32)

68
(1 RCT)

⊕⊕⊝⊝
LOW5

94 per 1000

55 per 1000
(10 to 311)

*The risk in the intervention group (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).

Apgar: A=Activity, P=Pulse, G=Grimace, A=Appearance, R= Respiration; ETT: Endotracheal Tube;

LMA: Laryngeal Mask Airway; RCT: Randomised controlled Trial; CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded three levels due to very wide Confidence interval, unclear risk of selection bias and serious study limitations (one of the study was a quasi‐random study)

2 Downgraded three levels due to unclear risk for selection bias and serious study limitations (one of the study was a quasi‐random study)

3Downgraded two levels due to unclear risk for selection bias and serious study limitations (one of the study was a quasi‐random study)

4Downgraded two levels due to very wide Confidence interval and unclear risk of selection bias

Downgraded two levels due to very wide Confidence interval and serious study limitations (one of the study was a quasi‐random study)

5Downgraded two levels due to serious study limitations as it was a quasi‐random study with high risk of selection, performance and detection bias

Figures and Tables -
Summary of findings 2. LMA compared to endotracheal intubation for neonatal resuscitation
Comparison 1. LMA versus BMV

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure with primary modality of resuscitation Show forest plot

5

660

Risk Ratio (M‐H, Fixed, 95% CI)

0.16 [0.09, 0.30]

2 Need for intubation Show forest plot

5

660

Risk Ratio (IV, Fixed, 95% CI)

0.24 [0.12, 0.47]

3 Time to spontaneous breathing Show forest plot

2

511

Mean Difference (IV, Fixed, 95% CI)

‐1.45 [‐2.98, 0.08]

4 Ventilation time [seconds] Show forest plot

4

610

Mean Difference (IV, Fixed, 95% CI)

‐18.90 [‐24.35, ‐13.44]

5 Apgar score ≤ 7 at 5 min Show forest plot

2

511

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.16, 0.74]

6 Admission to NICU Show forest plot

2

191

Risk Ratio (M‐H, Fixed, 95% CI)

0.6 [0.40, 0.90]

7 Death or HIE Show forest plot

2

191

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.17, 2.43]

Figures and Tables -
Comparison 1. LMA versus BMV
Comparison 2. LMA versus endotracheal intubation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure to correctly insert the device Show forest plot

3

158

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.17, 5.42]

2 Successful insertion of device at first attempt Show forest plot

2

108

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.89, 1.14]

3 Insertion time Show forest plot

2

108

Mean Difference (IV, Fixed, 95% CI)

0.31 [‐0.27, 0.88]

4 Ventilation time [seconds] Show forest plot

1

68

Mean Difference (IV, Fixed, 95% CI)

‐33.90 [‐73.11, 5.31]

5 Apgar score ≤7 at 5 minutes Show forest plot

2

108

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.34, 1.45]

6 Soft tissue trauma after device inserted Show forest plot

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.58, 6.91]

7 Death or HIE Show forest plot

1

68

Risk Ratio (M‐H, Fixed, 95% CI)

0.59 [0.11, 3.32]

Figures and Tables -
Comparison 2. LMA versus endotracheal intubation