Abstract
Background
Supraglottic airway devices perform more poorly and have lower oropharyngeal leak pressure in edentulous patients than in patients with teeth. The Ambu Aura Gain is a newer second generation supraglottic airway device.
Objective
This randomized clinical trial assessed the oropharyngeal leak pressure in edentulous patients using the Ambu Aura Gain with a gastric tube for insertion guidance and without insertion guidance.
Material and methods
Patients with ASA (American Society of Anesthesiology) physical status I–III were recruited. Primary outcome was oropharyngeal leak pressure after insertion. Secondary outcome parameters were oropharyngeal leak pressure 15 min and 30 min after insertion, insertion time, insertion attempts and glottis view through flexible fiberscope.
Results
In this study 72 patients aged between 51 and 90 years (mean 73 years) were randomly allocated to the “with guidance” (n = 36) or the “without guidance” group (n = 36). Mean (SD) oropharyngeal leak pressure in “with guidance” and “without guidance” group was 24 cm H2O and 24 cm H2O (ns), respectively. A difference was found in mean insertion time with guidance versus without guidance group 52 s (45 s) vs. 26 s (15 s) (p < 0.001). No difference was found in any of the other secondary outcome parameters.
Conclusion
A guided insertion technique does not improve oropharyngeal leak pressure of the Ambu AuraGain™ in edentulous patients. As the only difference is an increase in insertion time this technique is of no benefit for this population.
Zusammenfassung
Hintergrund
Supraglottische Atemwegshilfen zeigen bei zahnlosen Patienten im Vergleich zu Patienten mit Zähnen deutliche Schwächen in der Performance und erreichen niedrigere oropharyngeale Verschlussdrücke.
Ziel der Arbeit
Die Ambu AuraGain™ ist eine relativ neue supraglottische Atemwegshilfe der zweiten Generation. Ziel der vorliegenden randomisierten Studie ist es, den oropharyngealen Verschlussdruck der Ambu AuraGain™ in Abhängigkeit von der Insertionstechnik (mit Magensonde als Führungsschiene oder konventionell ohne Führungsschiene) zu untersuchen.
Material und Methoden
Es wurden Patienten mit einem ASA(American Society of Anesthesiology)-Status I–III eingeschlossen. Als primäre Outcome-Parameter wurde der oropharyngeale Verschlussdruck unmittelbar nach Insertion gewählt. Sekundäre Outcome-Parameter waren oropharyngealer Verschlussdruck 15 min und 30 min nach Insertion, die Insertionszeit, Anzahl der Insertionsversuche und die fiberooptische Lageevaluation der Glottis.
Ergebnisse
Insgesamt 72 Patienten zwischen 51 und 90 Jahren (Mittelwert: 73) wurden nach Randomisierung der Gruppe mit Führung (n = 36) oder ohne Führung (n = 36) zugewiesen. Der mittlere (SD) oropharyngeale Verschlussdruck betrug sowohl in der Gruppe mit als auch in der Gruppe ohne Führung 24 cm H2O (ns). Ein deutlicher Unterschied ergab sich in der Insertionszeit (Gruppe mit vs ohne Führung 66 s [45] vs. 32 s [15]; p < 0.001). Auch in alle weiteren sekundären Endpunkten zeigten sich keine signifikanten Unterschiede zwischen den zwei Einführungstechniken.
Diskussion
Unsere Studie zeigt, dass eine geführte Insertion bei zahnlosen Patienten den oropharyngealen Verschlussdruck der Ambu AuraGain™ Larynxmaske nicht verbessert. Jedoch im Vergleich zu anderen untersuchten supraglottischen Atemwegshilfen ist der oropharyngeale Verschlussdruck der Ambu AuraGain™ bei diesem Patientenkollektiv deutlich höher.
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Funding
This project was supported only by departmental resources.
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L. Gasteiger, H. Tauber, C. Velik-Salchner, M. Thoma, R. Fantin, V. Pustilnik, S. Neururer, C. Keller and B. Moser declare that they have no competing interests.
Ethical standards
This report describes human research. IRB contact information: Ethikkommission der Medizinischen Universität Innsbruck—Austria, Christoph-Probst Platz 1, Innrain 52, 6020 Innsbruck mail: i‑master@i-med.ac.at, https://www.i-med.ac.at/ethikkommission/index. This study was conducted with written informed consent from the study subjects. The study was conducted according to the Helsinki Declaration. This report describes a prospective randomized clinical trial. The author states that the report includes every item in the CONSORT checklist for a prospective randomised clinical trial. This was not an observational clinical study. This manuscript was screened for plagiarism using Plagiarism Checker.
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Gasteiger, L., Tauber, H., Velik-Salchner, C. et al. Guided vs. non-guided insertion of Ambu AuraGain™ in edentulous patients. Anaesthesist 70, 761–767 (2021). https://doi.org/10.1007/s00101-021-00914-x
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DOI: https://doi.org/10.1007/s00101-021-00914-x