Advertisement

Ambu® Aura Gain™ versus Ambu® Aura Once™ in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position

  • Birgit Stögermüller
  • Sigrid Ofner
  • Bernhard Ziegler
  • Christian Keller
  • Berthold Moser
  • Lukas Gasteiger
Reports of Original Investigations
  • 12 Downloads

Abstract

Purpose

The Ambu® Aura Gain™ is a new second-generation supraglottic airway device that—because of a wider curvature and a wide airway tube—allows fibreoptic intubation. The purpose of this study was to assess the oropharyngeal leak pressure of the Ambu® Aura GainTM compared with the Ambu® Aura Once™.

Methods

In this randomized non-blinded crossover trial with 50 patients aged 18 months to six years (10–20 kg), we compared the Ambu® Aura Gain™ and the Ambu® Aura Once™ for airway maintenance in anesthetized, non-paralyzed participants. Our primary outcome was oropharyngeal leak pressure. Time of insertion, success rates for each device, evaluation of fibreoptic view and ventilation quality during anesthesia, as well as possible complications (e.g., blood staining) were assessed.

Results

There were no differences in first and overall insertion attempt rates (Ambu® Aura Once™ 50/50 (100%) vs Ambu® Aura Gain™ 50/50 (100%). Mean (standard deviation) oropharyngeal leak pressure was found to be significantly higher for Ambu® Aura Gain™ than it was for Ambu® Aura Once™ [21 (7) vs 19 (6) cmH2O, respectively; mean difference [MD] − 2 cmH2O; 95% confidence interval [CI], − 3.8 to − 1.0; P = 0.001]. Mean (SD) insertion time was faster for Ambu® Aura Once™ than for Ambu® Aura Gain™ [8 (3) vs 10 (4) seconds, respectively; MD, − 2 sec; 95% CI, − 2.9 to − 1.2; P < 0.001]. There were no differences in ventilation quality, fibreoptic view, or blood staining.

Conclusion

We conclude that Ambu® Aura Gain™ is a good alternative to the Ambu® Aura Once™ and an efficient device for children in this age group.

Trial registration

www.clincaltrials.gov (NCT02811042). Registered 23 June 2016.

Ambu® Aura Gain™ versus Ambu® Aura Once™ chez des enfants : une étude randomisée à groupes croisés évaluant la pression de fuite oropharyngée et la vision au fibroscope

Résumé

Objectif

L’Ambu® Aura Gain™ est un nouveau dispositif supraglottique des voies respiratoires de deuxième génération qui, grâce à une plus grande courbure et à une grande ouverture de la lumière, permet l’intubation au fibroscope. L’objectif de cette étude était d’évaluer la pression de fuite oropharyngée de l’Ambu® Aura GainTM comparée à celle de l’Ambu® Aura Once™.

Méthodes

Dans cette étude randomisée, sans insu, à groupes croisés, ayant inclus 50 patients âgés de 18 mois à 6 ans (10 à 20 kg), nous avons comparé l’Ambu® Aura Gain™ et l’Ambu® Aura Once™ pour le maintien des voies aériennes chez des enfants anesthésiés, non paralysés. Notre critère d’évaluation principal était la pression de fuite oropharyngée. La rapidité d’insertion, le taux de succès pour chaque dispositif, l’évaluation de la visualisation au fibroscope et la qualité de la ventilation au cours de l’anesthésie, ainsi que les possibles complications (p. ex., présence de sang) ont été évalués.

Résultats

Il n’y a pas eu de différence sur les taux de succès de la première tentative d’insertion ou du taux global d’insertion (Ambu® Aura Once™, 50/50 [100 %] contre Ambu® Aura Gain™ 50/50 [100 %]). La pression de fuite oropharyngée moyenne (écart type) a été significativement plus élevée pour l’Ambu® Aura Gain™ que pour l’Ambu® Aura Once™ (respectivement, 21 [7] contre 19 [6] cmH2O; différence des moyennes [DM], − 2 cmH2O; intervalle de confiance [IC] à 95 % : − 3,8 à − 1,0; P < 0,001). Le temps d’insertion moyen (ET) était plus court avec l’Ambu® Aura Once™ qu’avec l’Ambu® Aura Gain™ (respectivement, 8 [3] secondes contre 10 [4] secondes; DM, − 2 s; IC à 95 %, − 2,9 à − 1,2; P < 0,001). Il n’y a pas eu de différence pour la qualité de la ventilation, la vue endoscopique ou la présence de sang.

Conclusion

Nous concluons que l’Ambu® Aura Gain™ constitue une bonne option de remplacement pour l’Ambu® Aura Once™ et est un dispositif efficace chez les enfants du groupe d’âge étudié.

Enregistrement de l’essai clinique

www.clincaltrials.gov (NCT02811042). Enregistré le 23 juin 2016.

Notes

Conflict of interest

Christian Keller consulted for laryngeal mask company.

Editorial responsibility

This submission was handled by Dr. Philip M. Jones, Associate Editor, Canadian Journal of Anesthesia.

Author contributions

Birgit Stögermüller contributed to the conception and design of the study as well as the acquisition, analysis, and interpretation of data. Sigrid Ofner and Bernhard Ziegler contributed to data acquisition. Christian Keller contributed to data analysis and interpretation as well as conception and design of the manuscript. Berthold Moser contributed to data interpretation. Lukas Gasteiger contributed to all aspects of manuscript preparation, including study conception, study design, data analysis, data interpretation, and drafting the article.

Funding

This project was supported only by departmental resources.

References

  1. 1.
    Pennant JH, White PF. The laryngeal mask airway. Its uses in anaesthesiology. Anesthesiology 1993; 79: 144-63.PubMedGoogle Scholar
  2. 2.
    Weiler N, Eberle B, Heinrichs W. The laryngeal mask airway: routine, risk, or rescue? Intensive Care Med 1999; 25: 761-2.CrossRefGoogle Scholar
  3. 3.
    Keller C, Brimacombe J, Bittersohl J, Lirk P, von Goedecke A. Aspiration and the laryngeal mask airway: three cases and a review of the literature. Br J Anaesth 2004; 93: 579-82.CrossRefGoogle Scholar
  4. 4.
    Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia 1996; 51:969-972.CrossRefGoogle Scholar
  5. 5.
    Brain AI, Verghese C, Strube PJ. The LMA ‘ProSeal’–a laryngeal mask with an oesophageal vent. Br J Anaesth 2000; 84: 650-4.CrossRefGoogle Scholar
  6. 6.
    Ghai B, Wig J. Comparison of different techniques of laryngeal mask placement in children. Curr Opin Anaesthesiol 2009; 22: 400-4.CrossRefGoogle Scholar
  7. 7.
    Jagannathan N, Hajduk J, Sohn L, et al. A randomised comparison of the Ambu® AuraGain™ and the LMA®-supreme in infants and children. Anaesthesia 2016; 71: 205-12.CrossRefGoogle Scholar
  8. 8.
    Rakhee G. Small is the new big: an overview of newer supraglottic airways for children. J Anaesthesiol Clin Pharmacol 2015; 31: 440-9.CrossRefGoogle Scholar
  9. 9.
    Gasteiger L, Ofner S, Stögermüller B, Ziegler B, Brimacombe J, Keller C. Randomized crossover study assessing oropharyngeal leak pressure and fiber optic positioning. Laryngeal Mask Airway Supreme™ versus Laryngeal Tube LTS II™ size 2 in non-paralyzed anesthetized children. Anaesthesist 2016; 65: 585-9.CrossRefGoogle Scholar
  10. 10.
    Gasteiger L, Brimacombe J, Oswald E, et al. LMA ProSealTM vs. i-GelTM in ventilated children: a randomised, crossover study using the size 2 mask. Acta Anaesthesiol Scand 2012; 56: 1321-4.CrossRefGoogle Scholar
  11. 11.
    Monclus E, Garces A, De Jose Maria B, Artes D, Marbrock M. Study of the adjustment of the Ambu laryngeal mask under magnetic resonance imaging. Paediatr Anaesth 2007; 17: 1182-6.CrossRefGoogle Scholar
  12. 12.
    Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg 2000; 91: 1017-20.CrossRefGoogle Scholar
  13. 13.
    Cook TM, Kelly FE. Time to abandon the ‘vintage’ laryngeal mask airway and adopt second-generation supraglottic airway devices as first choice. Br J Anaesth 2015; 115: 497-9.CrossRefGoogle Scholar
  14. 14.
    Keller C, Brimacombe JR, Keller K, Morris R. Comparison of four methods for assessing airway sealing pressure with the laryngeal mask airway in adult patients. Br J Anaesth 1999; 82: 286-7.CrossRefGoogle Scholar
  15. 15.
    Lopez-Gil M, Brimacombe J, Keller C. A comparison of four methods for assessing oropharyngeal leak pressure with the laryngeal mask airway (LMA) in paediatric patients. Paediatr Anaesth 2001; 11: 319-21.CrossRefGoogle Scholar
  16. 16.
    Brimacombe J, Berry A. A proposed fiber-optic scoring system to standardize the assessment of laryngeal mask airway position. Anesth Analg 1993; 76: 457.PubMedGoogle Scholar
  17. 17.
    Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth 2015; 25: 334-45.CrossRefGoogle Scholar
  18. 18.
    Weiss M, Engelhardt T. Proposal for the management of the unexpected difficult pediatric airway. Paediatr Anaesth 2010; 20: 454-64.CrossRefGoogle Scholar
  19. 19.
    APAGBI Paediatric Airway Guidelines. Available from URL: https://www.apagbi.org.uk/guidelines (accessed July 2018).
  20. 20.
    Bradley AE, White MC, Engelhardt T, Bayley G, Beringer RM. Current UK practice of pediatric supraglottic airway devices – a survey of members of the Association of Paediatric Anaesthetists of Great Britain and Ireland. Paediatr Anaesth 2013; 23: 1006-9.CrossRefGoogle Scholar
  21. 21.
    Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth 2011; 106: 617-31.Google Scholar
  22. 22.
    Moser B, Audigé L, Keller C, Brimacombe J, Gasteiger L, Bruppacher HR. Flexible bronchoscopic intubation through the AuraGain™ laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Can J Anesth 2017; 64: 1119-28.CrossRefGoogle Scholar

Copyright information

© Canadian Anesthesiologists' Society 2018

Authors and Affiliations

  1. 1.Department of Anaesthesia and Intensive Care MedicineParacelsus Medical UniversitySalzburgAustria
  2. 2.Department of Anaesthesia and Intensive CareGeneral Hospital SchwazSchwazAustria
  3. 3.Department of AnaesthesiaSchulthess KlinikZurichSwitzerland
  4. 4.Department of Anaesthesia and Intensive CareMedical University of InnsbruckInnsbruckAustria

Personalised recommendations