ProSeal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adults undergoing elective surgery

Muhammad Qamarul Hoda; Khalid Samad; Hameed Ullah

doi:10.1002/14651858.CD009026.pub2

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Figure 1

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 2

Study flow diagram.

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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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Analysis 1.1

Comparison 1 Failure to mechanically ventilate, Outcome 1 Inadequate oxygenation.

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Analysis 2.1

Comparison 2 Failure to insert or use of alternate device, Outcome 1 Failure to insert or use of alternate device.

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Analysis 3.1

Comparison 3 Effective airway time (seconds), Outcome 1 Effective airway time (seconds).

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Analysis 4.1

Comparison 4 Peak airway pressure during positive pressure ventilation, Outcome 1 Peak airway pressure during positive pressure ventilation.

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Analysis 5.1

Comparison 5 Oropharyngeal leak pressure (seal pressure), Outcome 1 Oropharyngeal leak pressure (seal pressure) (cm H₂O).

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Analysis 6.1

Comparison 6 Complications, Outcome 1 Mucosal injury.

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Analysis 6.2

Comparison 6 Complications, Outcome 2 Sore throat.

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Analysis 6.3

Comparison 6 Complications, Outcome 3 Bronchospasm.

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Analysis 6.4

Comparison 6 Complications, Outcome 4 Gastric insufflation.

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Analysis 6.5

Comparison 6 Complications, Outcome 5 Regurgitation.

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Analysis 6.6

Comparison 6 Complications, Outcome 6 Coughing.

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Analysis 6.7

Comparison 6 Complications, Outcome 7 Excessive leak.

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Summary of findings for the main comparison. ProSeal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adult patients undergoing elective surgery

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 Settings: hospital operation theatres in Australia, Austria, France, Germany, Italy, India, Japan, South Korea, Spain, USA Intervention: ProSeal laryngeal mask airway (pLMA) Comparison: Classic laryngeal mask airway (cLMA)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	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)	⊕⊝⊝⊝ very low^a
Inadequate ventilation ( ETCO₂ > 45 mm Hg)	See comment	See comment	Not estimable	80 (1 study)	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 (2 studies)	⊕⊕⊝⊝ Low^b	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)	⊕⊕⊝⊝ Low^c
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 (6 studies)	⊕⊕⊝⊝ Low^d
Sore throat	194 per 1000	150 per 1000 (107 to 210)	RR 0.77 (0.55 to 1.08)	653 (5)	⊕⊕⊝⊝ Low^e
Regurgitation	17 per 1000	13 per 1000 (4 to 45)	RR 0.8 (0.24 to 2.69)	597 (4)	⊕⊕⊝⊝ Low^f
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). 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.
^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.

Summary of findings for the main comparison. ProSeal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adult patients undergoing elective surgery

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Comparison 1. Failure to mechanically ventilate

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]

Comparison 1. Failure to mechanically ventilate

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Comparison 2. Failure to insert or use of alternate device

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]

Comparison 2. Failure to insert or use of alternate device

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Comparison 3. Effective airway time (seconds)

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]

Comparison 3. Effective airway time (seconds)

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Comparison 4. Peak airway pressure during positive pressure ventilation

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]

Comparison 4. Peak airway pressure during positive pressure ventilation

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Comparison 5. Oropharyngeal leak pressure (seal pressure)

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]

Comparison 5. Oropharyngeal leak pressure (seal pressure)

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Comparison 6. Complications

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]

Comparison 6. Complications

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