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Pediatric supraglottic airway devices in clinical practice: A prospective observational study
BACKGROUND: Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Su...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5581452/ https://www.ncbi.nlm.nih.gov/pubmed/28865448 http://dx.doi.org/10.1186/s12871-017-0403-6 |
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author | Kleine-Brueggeney, Maren Gottfried, Anne Nabecker, Sabine Greif, Robert Book, Malte Theiler, Lorenz |
author_facet | Kleine-Brueggeney, Maren Gottfried, Anne Nabecker, Sabine Greif, Robert Book, Malte Theiler, Lorenz |
author_sort | Kleine-Brueggeney, Maren |
collection | PubMed |
description | BACKGROUND: Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. METHODS: This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH(2)O ± 10%. RESULTS: None of the SGA showed a mean airway leak pressure of 20 cmH(2)O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH(2)O, Air-Q® 15.9 (3.2) cmH(2)O, Ambu® Aura-i™ 17.3 (3.7) cmH(2)O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™, <p = 0.005). Insertion was rated easiest with the LMA Supreme™ (very easy in 97% vs. Air-Q® 70%, Ambu® Aura-i™ 72%, p < 0.001). Fiberoptic view was similar between the SGA. Adverse events were rare. CONCLUSIONS: Airway leak pressures ranged from 16 to 18 cmH(2)O, enabling positive pressure ventilation with all successful SGA. The highest success rates were achieved by the LMA Supreme™, which was also rated easiest to insert. TRIALS REGISTRATION: ClinicalTrials.gov, identifier NCT01625858. Registered 31 May 2012. |
format | Online Article Text |
id | pubmed-5581452 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-55814522017-09-06 Pediatric supraglottic airway devices in clinical practice: A prospective observational study Kleine-Brueggeney, Maren Gottfried, Anne Nabecker, Sabine Greif, Robert Book, Malte Theiler, Lorenz BMC Anesthesiol Research Article BACKGROUND: Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. METHODS: This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH(2)O ± 10%. RESULTS: None of the SGA showed a mean airway leak pressure of 20 cmH(2)O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH(2)O, Air-Q® 15.9 (3.2) cmH(2)O, Ambu® Aura-i™ 17.3 (3.7) cmH(2)O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™, <p = 0.005). Insertion was rated easiest with the LMA Supreme™ (very easy in 97% vs. Air-Q® 70%, Ambu® Aura-i™ 72%, p < 0.001). Fiberoptic view was similar between the SGA. Adverse events were rare. CONCLUSIONS: Airway leak pressures ranged from 16 to 18 cmH(2)O, enabling positive pressure ventilation with all successful SGA. The highest success rates were achieved by the LMA Supreme™, which was also rated easiest to insert. TRIALS REGISTRATION: ClinicalTrials.gov, identifier NCT01625858. Registered 31 May 2012. BioMed Central 2017-09-02 /pmc/articles/PMC5581452/ /pubmed/28865448 http://dx.doi.org/10.1186/s12871-017-0403-6 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Kleine-Brueggeney, Maren Gottfried, Anne Nabecker, Sabine Greif, Robert Book, Malte Theiler, Lorenz Pediatric supraglottic airway devices in clinical practice: A prospective observational study |
title | Pediatric supraglottic airway devices in clinical practice: A prospective observational study |
title_full | Pediatric supraglottic airway devices in clinical practice: A prospective observational study |
title_fullStr | Pediatric supraglottic airway devices in clinical practice: A prospective observational study |
title_full_unstemmed | Pediatric supraglottic airway devices in clinical practice: A prospective observational study |
title_short | Pediatric supraglottic airway devices in clinical practice: A prospective observational study |
title_sort | pediatric supraglottic airway devices in clinical practice: a prospective observational study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5581452/ https://www.ncbi.nlm.nih.gov/pubmed/28865448 http://dx.doi.org/10.1186/s12871-017-0403-6 |
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