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Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study

BACKGROUND: : Supraglottic airway (SGA) device with non-inflatable cuff reduce the airway complications associated with cuff hyperinflation. The aim of the study is to determine whether the default setting of Supreme is as effective as the non-inflatable cuff devices. The oropharyngeal leak pressure...

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Autores principales: Hwang, Jagyung, Hong, Boohwi, Kim, Yoon-Hee, Lee, Won Hyung, Jo, Yumin, Youn, SooKyoung, Lim, Chae Seong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417551/
https://www.ncbi.nlm.nih.gov/pubmed/30855468
http://dx.doi.org/10.1097/MD.0000000000014746
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author Hwang, Jagyung
Hong, Boohwi
Kim, Yoon-Hee
Lee, Won Hyung
Jo, Yumin
Youn, SooKyoung
Lim, Chae Seong
author_facet Hwang, Jagyung
Hong, Boohwi
Kim, Yoon-Hee
Lee, Won Hyung
Jo, Yumin
Youn, SooKyoung
Lim, Chae Seong
author_sort Hwang, Jagyung
collection PubMed
description BACKGROUND: : Supraglottic airway (SGA) device with non-inflatable cuff reduce the airway complications associated with cuff hyperinflation. The aim of the study is to determine whether the default setting of Supreme is as effective as the non-inflatable cuff devices. The oropharyngeal leak pressure was measured and compared between the Supreme and Air-Q, a typical non-inflatable cuff device. We hypothesized that the default setting of Supreme is non-inferior to the the Air-Q self-pressurized (SP) in respect to the oropharyngeal leak pressure. METHODS: : Eighty-four patients aged 1 to 7 years who were scheduled for general anesthesia, participated in the study. The patients were randomly assigned to Supreme group (n = 41) or Air-Q SP group (n = 43). We considered that the primary outcome, oropharyngeal leak pressure of Supreme group would be non-inferior to the Air-Q SP group, within 3 cmH(2)O. Other outcomes included tidal volume loss, difficulty of insertion, insertion time, and complications. RESULTS: : The oropharyngeal leak pressure of the Supreme and Air-Q SP was 19.9 ± 4.1 cm H(2)O and 17.4 ± 2.9 cm H(2)O, respectively. The mean differences of 2 devices (Air-Q SP—Supreme) were −2.5 cm H(2)O, (95% confidence interval [−4.0 to −0.9], P = .002). The upper CI was smaller than the non-inferiorty margin (3 cm H(2)O). This result suggested that the default setting of Supreme was superior to the Air-Q SP with respect to the oropharyngeal leak pressure. However, there were no significant differences in tidal volume loss over time, ease of device insertion score, insertion time, and complications. CONCLUSIONS: : The Supreme can be used in the default setting in pediatric patients accordingly in terms of tolerable leak pressure and the stability for mechanical ventilation compared with Air-Q SP.
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spelling pubmed-64175512019-03-16 Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study Hwang, Jagyung Hong, Boohwi Kim, Yoon-Hee Lee, Won Hyung Jo, Yumin Youn, SooKyoung Lim, Chae Seong Medicine (Baltimore) Research Article BACKGROUND: : Supraglottic airway (SGA) device with non-inflatable cuff reduce the airway complications associated with cuff hyperinflation. The aim of the study is to determine whether the default setting of Supreme is as effective as the non-inflatable cuff devices. The oropharyngeal leak pressure was measured and compared between the Supreme and Air-Q, a typical non-inflatable cuff device. We hypothesized that the default setting of Supreme is non-inferior to the the Air-Q self-pressurized (SP) in respect to the oropharyngeal leak pressure. METHODS: : Eighty-four patients aged 1 to 7 years who were scheduled for general anesthesia, participated in the study. The patients were randomly assigned to Supreme group (n = 41) or Air-Q SP group (n = 43). We considered that the primary outcome, oropharyngeal leak pressure of Supreme group would be non-inferior to the Air-Q SP group, within 3 cmH(2)O. Other outcomes included tidal volume loss, difficulty of insertion, insertion time, and complications. RESULTS: : The oropharyngeal leak pressure of the Supreme and Air-Q SP was 19.9 ± 4.1 cm H(2)O and 17.4 ± 2.9 cm H(2)O, respectively. The mean differences of 2 devices (Air-Q SP—Supreme) were −2.5 cm H(2)O, (95% confidence interval [−4.0 to −0.9], P = .002). The upper CI was smaller than the non-inferiorty margin (3 cm H(2)O). This result suggested that the default setting of Supreme was superior to the Air-Q SP with respect to the oropharyngeal leak pressure. However, there were no significant differences in tidal volume loss over time, ease of device insertion score, insertion time, and complications. CONCLUSIONS: : The Supreme can be used in the default setting in pediatric patients accordingly in terms of tolerable leak pressure and the stability for mechanical ventilation compared with Air-Q SP. Wolters Kluwer Health 2019-03-08 /pmc/articles/PMC6417551/ /pubmed/30855468 http://dx.doi.org/10.1097/MD.0000000000014746 Text en Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
spellingShingle Research Article
Hwang, Jagyung
Hong, Boohwi
Kim, Yoon-Hee
Lee, Won Hyung
Jo, Yumin
Youn, SooKyoung
Lim, Chae Seong
Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study
title Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study
title_full Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study
title_fullStr Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study
title_full_unstemmed Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study
title_short Comparison of laryngeal mask airway supreme(TM) as non-inflatable cuff device and self-pressurized air-Q(TM) in children: Randomized controlled non-inferiority study
title_sort comparison of laryngeal mask airway supreme(tm) as non-inflatable cuff device and self-pressurized air-q(tm) in children: randomized controlled non-inferiority study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417551/
https://www.ncbi.nlm.nih.gov/pubmed/30855468
http://dx.doi.org/10.1097/MD.0000000000014746
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