Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2017 Jul 20;7(7):CD009026.
doi: 10.1002/14651858.CD009026.pub2.

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

Affiliations
Meta-Analysis

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

Muhammad Qamarul Hoda et al. Cochrane Database Syst Rev. .

Abstract

Background: The development of supraglottic airway devices has revolutionized airway management during general anaesthesia. Two devices are widely used in clinical practice to facilitate positive pressure ventilation: the ProSeal laryngeal mask airway (pLMA) and the Classic laryngeal mask airway (cLMA). It is not clear whether these devices have important clinical differences in terms of efficacy or complications.

Objectives: To compare the effectiveness of the ProSeal laryngeal mask airway (pLMA) and the Classic LMA (cLMA) for positive pressure ventilation in adults undergoing elective surgery.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 3) in the Cochrane Library; MEDLINE (Ovid SP, 1997 to April 2017); Embase (Ovid SP, 1997 to April 2017); the Institute for Scientific Information (ISI) Web of Science (1946 to April 2017); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO host, 1982 to April 2017).We searched trial registries for ongoing studies to April 2017.We did not impose language restrictions. We restricted our search to the time from 1997 to April 2017 because pLMA was introduced into clinical practice in the year 2000.

Selection criteria: We included randomized controlled trials (RCTs) that compared the effectiveness of pLMA and cLMA for positive pressure ventilation in adults undergoing elective surgery. We planned to include only data related to the first phase of cross-over RCTs.

Data collection and analysis: We used standard methodological procedures expected by the Cochrane Collaboration.

Main results: We included eight RCTs that involved a total of 829 participants (416 and 413 participants in the pLMA and cLMA groups, respectively). We identified six cross-over studies that are awaiting classification; one is completed but has not been published, and data related to the first treatment period for the other five studies were not yet available. Seven included studies provided data related to the primary outcome, and eight studies provided data related to more than one secondary outcome.Our analysis was hampered by the fact that a large proportion of the included studies reported no events in either study arm. No studies reported significant differences between devices in relation to the primary review outcome: failure to adequately mechanically ventilate. We evaluated this outcome by assessing two variables: inadequate oxygenation (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.17 to 3.31; four studies, N = 617) and inadequate ventilation (not estimable; one study, N = 80).More time was required to establish an effective airway using pLMA (mean difference (MD) 10.12 seconds, 95% CI 5.04 to 15.21; P < 0.0001; I² = 73%; two studies, N = 434). Peak airway pressure during positive pressure ventilation was lower in cLMA participants (MD 0.84, 95% CI 0.02 to 1.67; P = 0.04; I² = 0%; four studies, N = 259). Mean oropharyngeal leak (OPL) pressure was higher in pLMA participants (MD 6.93, 95% CI 4.23 to 9.62; P < 0.00001; I² = 87%; six studies, N = 709).The quality of evidence for all outcomes, as assessed by GRADE score, is low mainly owing to issues related to blinding and imprecision.Data show no important differences between devices with regard to failure to insert the device, use of an alternate device, mucosal injury, sore throat, bronchospasm, gastric insufflation, regurgitation, coughing, and excessive leak. Data were insufficient to allow estimation of differences for obstruction related to the device. None of the studies reported postoperative nausea and vomiting as an outcome.

Authors' conclusions: We are uncertain about the effects of either of the airway devices in terms of failure of oxygenation or ventilation because there were very few events. Results were uncertain in terms of differences for several complications. Low-quality evidence suggests that the ProSeal laryngeal mask airway makes a better seal and therefore may be more suitable than the Classic laryngeal mask airway for positive pressure ventilation. The Classic laryngeal mask airway may be quicker to insert, but this is unlikely to be clinically meaningful.

PubMed Disclaimer

Conflict of interest statement

  1. Muhammad Qamarul Hoda: none known.

  2. Khalid Samad: none known.

  3. Hameed Ullah: none known.

Figures

1
1
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
Study flow diagram.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Failure to mechanically ventilate, Outcome 1 Inadequate oxygenation.
2.1
2.1. Analysis
Comparison 2 Failure to insert or use of alternate device, Outcome 1 Failure to insert or use of alternate device.
3.1
3.1. Analysis
Comparison 3 Effective airway time (seconds), Outcome 1 Effective airway time (seconds).
4.1
4.1. Analysis
Comparison 4 Peak airway pressure during positive pressure ventilation, Outcome 1 Peak airway pressure during positive pressure ventilation.
5.1
5.1. Analysis
Comparison 5 Oropharyngeal leak pressure (seal pressure), Outcome 1 Oropharyngeal leak pressure (seal pressure) (cm H₂O).
6.1
6.1. Analysis
Comparison 6 Complications, Outcome 1 Mucosal injury.
6.2
6.2. Analysis
Comparison 6 Complications, Outcome 2 Sore throat.
6.3
6.3. Analysis
Comparison 6 Complications, Outcome 3 Bronchospasm.
6.4
6.4. Analysis
Comparison 6 Complications, Outcome 4 Gastric insufflation.
6.5
6.5. Analysis
Comparison 6 Complications, Outcome 5 Regurgitation.
6.6
6.6. Analysis
Comparison 6 Complications, Outcome 6 Coughing.
6.7
6.7. Analysis
Comparison 6 Complications, Outcome 7 Excessive leak.

Update of

References

References to studies included in this review

Ambi 2011 {published data only}
    1. Ambi U, Koppal R, Joshi C, Prakashappa DS, Iyer H. LMA Classic and LMA proseal: a comparative study in paralyzed anaesthetized patients. Journal of Clinical and Diagnostic Research 2011;5:940‐3.
Brimacombe 2002 {published data only}
    1. Brimacombe J, Keller C, Fullekrug B, Agrò F, Rosenblatt W, Dierdorf SF, et al. A multicenter study comparing the ProSeal and Classic laryngeal mask airway in anesthetized, nonparalyzed patients. Anesthesiology 2002;96(2):289‐95. [PUBMED: 11818758] - PubMed
Keller 2000 {published data only}
    1. Keller C, Brimacombe J. Mucosal pressure and oropharyngeal leak pressure with the ProSeal versus laryngeal mask airway in anaesthetized paralysed patients. British Journal of Anaesthesia 2000;85(2):262‐6. [PUBMED: 10992836] - PubMed
Khazin 2008 {published data only}
    1. Khazin V, Ezri T, Yishai R, Sessler DI, Serour F, Szmuk P, et al. Gastroesophageal regurgitation during anesthesia and controlled ventilation with six airway devices. Journal of Clinical Anesthesia 2008;20(7):508‐13. [PUBMED: 19019665] - PubMed
Lu 2002 {published data only}
    1. Lu PP, Brimacombe J, Yang C, Shyr M. ProSeal versus the Classic laryngeal mask airway for positive pressure ventilation during laparoscopic cholecystectomy. British Journal of Anaesthesia 2002;88(6):824‐7. [PUBMED: 12173201] - PubMed
Natalini 2003a {published data only}
    1. Natalini G, Franceschetti ME, Pantelidi MT, Rosano A, Lanza G, Bernardini A. Comparison of the standard laryngeal mask airway and the ProSeal laryngeal mask airway in obese patients. British Journal of Anaesthesa 2003;90(3):323‐6. [PUBMED: 12594145] - PubMed
Natalini 2003b {published data only}
    1. Natalini G, Lanza G, Rosano A, Dell'Agnolo P, Bernardini A. Standard laryngeal mask airway and LMA‐ProSeal during laparoscopic surgery. Journal of Clinical Anesthesia 2003;15(6):428‐32. - PubMed
Shin 2010 {published data only}
    1. Shin WJ, Cheong YS, Yang HS, Nishiyama T. The supraglottic airway I‐gel in comparison with ProSeal laryngeal mask airway and classic laryngeal mask airway in anaesthetized patients. European Journal of Anaesthesiology 2010;27(7):598‐601. [PUBMED: 19915475] - PubMed

References to studies excluded from this review

Brain 2000 {published data only}
    1. Brain AI, Verghese C, Strube PJ. The LMA 'ProSeal' ‐ a laryngeal mask with an oesophageal vent. British Journal of Anaesthesia 2000;84(5):650‐4. [PUBMED: 10844848] - PubMed
Francksen 2007 {published data only}
    1. Francksen H, Bein B, Cavus E, Renner J, Scholz J, Steinfath M, et al. Comparison of LMA Unique, Ambu laryngeal mask and Soft Seal laryngeal mask during routine surgical procedures. European Journal of Anaesthesiology 2007;24(2):134‐40. [PUBMED: 16895620] - PubMed
Goldmann 2011 {published data only}
    1. Goldmann K, Gerlach M, Bornträger C. ProSeal™ laryngeal mask in normal weight and obese patients: oxygenation under pressure‐controlled ventilation and different end‐expiratory pressures [ProSeal® ‐ Kehlkopfmaske in normalgewichtigen und adipösen Patienten]. Anaesthesist 2011;60(10):908‐15. [PUBMED: 21796447] - PubMed
Hosten 2009 {published data only}
    1. Hosten T, Gurkan Y, Ozdamar D, Tekin M, Toker K, Solak M. A new supraglottic airway device: LMA‐supreme, comparison with LMA‐Proseal. Acta Anaesthesiologica Scandinavica 2009;53(7):852‐7. [PUBMED: 19426239] - PubMed
Lopez 2011 {published data only}
    1. López AM, Valero R, Hurtado P, Gambús P, Pons M, Anglada T. Comparison of the LMA Supreme™ with the LMA Proseal™ for airway management in patients anaesthetized in prone position. British Journal of Anaesthesia 2011;107(2):265‐71. [PUBMED: 21576096] - PubMed
Maltby 2003 {published data only}
    1. Maltby JR, Beriault MT, Watson NC, Liepert DJ, Fick GH. LMA‐Classic (TM) and LMA‐ProSeal (TM) are effective alternatives to endotracheal intubation for gynecologic laparoscopy. Canadian Journal of Anesthesia 2003;50(1):71‐7. [PUBMED: 12514155] - PubMed
Seet 2010 {published data only}
    1. Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, et al. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. European Journal of Anaesthesiology 2010;27(7):602‐7. [PUBMED: 20540172] - PubMed
Shariffuddin 2008 {published data only}
    1. Shariffuddin II, Wang CY. Randomised crossover comparison of the Ambu AuraOnce Laryngeal Mask with the LMA Classic laryngeal mask airway in paralysed anaesthetised patients. Anaesthesia 2008;63(1):82‐5. [PUBMED: 18086075] - PubMed
Tham 2010 {published data only}
    1. Tham HM, Tan SM, Woon KL, Zhao YD. A comparison of the Supreme laryngeal mask airway with the ProSeal laryngeal mask airway in anesthetized paralyzed adult patients: a randomized crossover study. Canadian Journal of Anesthesia 2010;57(7):672‐8. [PUBMED: 20411444] - PubMed
Verghese 2008 {published data only}
    1. Verghese C, Ramaswamy B. LMA ‐ Supreme ‐ a new single‐use LMA with gastric access: a report on its clinical efficacy. British Journal of Anaesthesia 2008;101:405‐10. [PUBMED: 18559351] - PubMed

References to studies awaiting assessment

Brimacombe 2000 {published data only}
    1. Brimacombe J, Keller C. The ProSeal laryngeal mask airway: a randomized, crossover study with the standard laryngeal mask airway in paralyzed, anesthetized patients. Anesthesiology 2000;93(1):104‐9. [PUBMED: 10861152] - PubMed
Brimacombe 2001 {published data only}
    1. Brimacombe J, Keller C, Boehler M, Pühringer F. Positive pressure ventilation with the ProSeal versus classic laryngeal mask airway: a randomized, crossover study of healthy female patients. Anesthesia and Analgesia 2001;93(5):1351–3. [PUBMED: 11682428 ] - PubMed
Cook 2002 {published data only}
    1. Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, et al. Randomized crossover comparison of the ProSeal with the Classic laryngeal mask airway in unparalysed anaesthetized patients. British Journal of Anaesthesia 2002;88(4):527‐33. [PUBMED: 12066729] - PubMed
Li 2007 {published data only}
    1. Li CW, Xue FS, Mao P, Xu YC, Liu Y, Zhang GH, et al. An auto control comparison of the use of ProSeal laryngeal mask airway and standard laryngeal mask airway for positive pressure ventilation. Chinese Critical Care Medicine 2007;19(2):81‐5. [00706531] - PubMed
Natalini 2003c {published data only}
    1. Natalini G, Rosano A, Lanza G, Martinelli E, Pletti C, Bernardini A. Resistive load of laryngeal mask airway and ProSeal laryngeal mask airway in mechanically ventilated patients. Acta Anaesthesiologica Scandinavica 2003;6(47):761‐4. [PUBMED: 12803596] - PubMed
NCT02979171 {unpublished data only}
    1. Comparison in difficult airway scenario induced in patients with Laryngeal Mask Airway (LMA) ‐ Classic™, LMA™ ‐ Flexible and LMA ‐ Proseal™. https://clinicaltrials.gov/ct2/show/record/NCT02979171?term=classic+lary... (first received 5 April 2016).

Additional references

Benumof 1992
    1. Benumof JL. Laryngeal mask airway. Indications and contraindications. Anesthesiology 1992;77(5):843‐6. [MEDLINE: ] - PubMed
Benumof 1996
    1. Benumof JL. Laryngeal mask airway and the ASA difficult airway algorithm. Anesthesiology 1996;84(3):686‐99. [MEDLINE: ] - PubMed
Bernardini 2009
    1. Bernardini A, Natalini G. Risk of pulmonary aspiration with laryngeal mask airway and tracheal tube: analysis on 65 712 procedures with positive pressure ventilation. Anaesthesia 2009;64(12):1289‐94. [MEDLINE: ] - PubMed
Blanc 1974
    1. Blanc VF, Tremblay NA. The complications of tracheal intubation: a new classification with a review of the literature. Anesthesia and Analgesia 1974;53(2):202‐13. [MEDLINE: ] - PubMed
Bogetz 1994
    1. Bogetz MS. The laryngeal mask airway ‐ role in managing the difficult airway. International Anesthesiology Clinics 1994;32(4):109‐17. [MEDLINE: ] - PubMed
Brain 1983
    1. Brain AI. The laryngeal mask ‐ a new concept in airway management. British Journal of Anaesthesia 1983;55(8):801‐5. [MEDLINE: ] - PubMed
Brain 1985
    1. Brain AI, McGhee TD, McAteer EJ, Thomas A, Abu‐Saad MA, Bushman JA. The laryngeal mask airway. Development and preliminary trials of a new type of airway. Anaesthesia 1985;40(4):356‐61. [MEDLINE: ] - PubMed
Brimacombe 1995
    1. Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta‐analysis. Canadian Journal of Anaesthesia 1995;42(11):1017‐23. [MEDLINE: ] - PubMed
Brimacombe 1995a
    1. Brimacombe JR, Berry A. The incidence of aspiration associated with the laryngeal mask airway: a meta‐analysis of published literature. Journal of Clinical Anesthesia 1995;7(4):297‐305. [MEDLINE: ] - PubMed
Brimacombe 1996
    1. Brimacombe J. Analysis of 1500 laryngeal mask uses by one anaesthetist in adults undergoing routine anaesthesia. Anaesthesia 1996;51(1):76‐80. [MEDLINE: ] - PubMed
Brimacombe 2002a
    1. Brimacombe J, Keller C. The ProSeal laryngeal mask airway. Anesthesiology Clinics of North America 2002;20(4):871‐91. [PUBMED: 12512267] - PubMed
Cook 2005
    1. Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Canadian Journal of Anesthesia 2005;52(7):739‐60. [PUBMED: 16103390] - PubMed
DerSimonian 1986
    1. DerSimonian R, Laird N. Meta‐analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177‐88. [MEDLINE: ] - PubMed
Devitt 1994
    1. Devitt JH, Wenstone R, Noel AG, O'Donnell MP. The laryngeal mask airway and positive‐pressure ventilation. Anesthesiology 1994;80(3):550‐5. [MEDLINE: ] - PubMed
Evans 2002
    1. Evans NR, Gardner SV, James MF. ProSeal laryngeal mask protects against aspiration of fluid in the pharynx. British Journal of Anaesthesia 2002;88(4):584‐7. [MEDLINE: ] - PubMed
GRADEpro GDT 2014 [Computer program]
    1. GRADE Working Group, McMaster University. GRADEpro GDT. Hamilton (ON): GRADE Working Group, McMaster University, 2014 (accessed before 20 February 2017).
Griffin 1990
    1. Griffin RM, Hatcher IS. Aspiration pneumonia and the laryngeal mask airway. Anaesthesia 1990;45(12):1039‐40. [MEDLINE: ] - PubMed
Guyatt 2008
    1. Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck‐Ytter Y, Schünemann HJ. What is "quality of evidence" and why is it important to clinicians?. British Medical Journal 2008;336(7651):995‐8. [MEDLINE: ] - PMC - PubMed
Higgins 2011
    1. Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. handbook.cochrane.org.
Higgins 2011a
    1. Higgins JP, Deeks J. Obtaining standard deviations from standard errors and confidence intervals for group means. Cochrane Handbook for Systematic Reviews of Interventions, 2011, issue 5.
Jones 1995
    1. Jones JR. Laryngeal mask airway: an alternative for the difficult airway. AANA Journal 1995;63(5):444‐9. [MEDLINE: ] - PubMed
Jüni 2001
    1. Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. British Medical Journal 2001;323(7303):42‐6. [MEDLINE: ] - PMC - PubMed
Keller 2004
    1. Keller C, Brimacombe J, Bittersohl J, Lirk P, Goedecke A. Aspiration and the laryngeal mask airway: three cases and a review of the literature. British Journal of Anaesthesia 2004;93(4):579‐82. [MEDLINE: ] - PubMed
Lopez‐Gil 2005
    1. Lopez‐Gil M, Brimacombe J. The ProSeal laryngeal mask airway in children. Paediatric Anaesthesia 2005;15(3):229‐34. [MEDLINE: ] - PubMed
Luckhaupt 1986
    1. Luckhaupt H, Brusis T. History of intubation. Laryngologie, Rhinologie, Otologie 1986;65(9):506‐10. [MEDLINE: ] - PubMed
Maltby 2000
    1. Maltby JR, Beriault MT, Watson NC, Fick GH. Gastric distension and ventilation during laparoscopic cholecystectomy: LMA‐Classic vs. tracheal intubation. Canadian Journal of Anaesthesia 2000;47(7):622‐6. [MEDLINE: ] - PubMed
Mark 2003
    1. Mark DA. Protection from aspiration with the LMA‐ProSeal after vomiting: a case report. Canadian Journal of Anaesthesia 2003;50(1):78‐80. [MEDLINE: ] - PubMed
McHardy 1999
    1. McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia 1999;54(5):444‐53. [MEDLINE: ] - PubMed
RevMan 5.3 [Computer program]
    1. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Szmuk 2008
    1. Szmuk P, Ezri T, Evron S, Roth Y, Katz J. A brief history of tracheostomy and tracheal intubation, from the bronze age to the space age. Intensive Care Medicine 2008;34(2):222‐8. [MEDLINE: ] - PubMed
Todesco 1993
    1. Todesco J, Dodd C, Williams RT. Laryngeal mask airway: defining the limits. Canadian Journal of Anesthesia 1993;40(9):900‐1. [MEDLINE: ] - PubMed
Van Damme 1994
    1. Damme E. The laryngeal mask in ambulatory anesthesia. An evaluation of 5,000 ambulatory anesthesia incidents [Die Kehlkopfmaske in der ambulanten Anästhesie. Eine Auswertung von 5000 ambulanten Narkosen]. Anästhesiologie, Intensivmedizin, Notfallmedizin, Schmerztherapie 1994;29(5):284‐6. [MEDLINE: ] - PubMed
Verghese 1996
    1. Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and non conventional usage. Anesthesia and Analgesia 1996;82(1):129‐33. [MEDLINE: ] - PubMed
Villars 2005
    1. Villars P, Koczka E, Haynie C. The use of the laryngeal mask airway with mechanical positive pressure ventilation. AANA Journal 2005;73(1):18. [MEDLINE: ] - PubMed
Wan 2014
    1. Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC medical research methodology 2014;14(1):135. [PUBMED: 25524443] - PMC - PubMed
Wat 2003
    1. Wat LI. The laryngeal mask airway for oral and maxillofacial surgery. International Anesthesiology Clinics 2003;41(3):29‐56. [MEDLINE: ] - PubMed
Zhang 2012
    1. Zhang X, Chen M, Li Q. The ProSeal laryngeal mask airway is more effective than the LMA‐Classic in pediatric anesthesia: a meta‐analysis. Journal of Clinical Anesthesia 2012;24(8):639‐46. [PUBMED: 23122975] - PubMed

References to other published versions of this review

Qamarul Hoda 2011
    1. Qamarul Hoda M, Samad K, Ullah H. Proseal versus Classic laryngeal mask airway (LMA) for positive pressure ventilation in adult patients undergoing elective surgery. Cochrane Database of Systematic Reviews 2011, Issue 3. [DOI: 10.1002/14651858.CD009026] - DOI - PMC - PubMed

LinkOut - more resources