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Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial
BACKGROUND: With the increasing amount of geriatric surgery, it has become a great challenge for anesthesiologists to reduce the incidence of postoperative pulmonary complications (PPCs). The two most popular airway management methods, laryngeal mask airway (LMA) and endotracheal intubation (ETI), b...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6505282/ https://www.ncbi.nlm.nih.gov/pubmed/31068221 http://dx.doi.org/10.1186/s13063-019-3351-2 |
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author | Zhu, Ling Shi, Xiao Yin, Suqing Yin, Jiemin Zhu, Ziyu Gao, Xiong Jiao, Yingfu Yu, Weifeng Yang, Liqun |
author_facet | Zhu, Ling Shi, Xiao Yin, Suqing Yin, Jiemin Zhu, Ziyu Gao, Xiong Jiao, Yingfu Yu, Weifeng Yang, Liqun |
author_sort | Zhu, Ling |
collection | PubMed |
description | BACKGROUND: With the increasing amount of geriatric surgery, it has become a great challenge for anesthesiologists to reduce the incidence of postoperative pulmonary complications (PPCs). The two most popular airway management methods, laryngeal mask airway (LMA) and endotracheal intubation (ETI), both have their unique advantages in specific clinical settings. For the purpose of helping clinicians make better decisions on airway management during geriatric surgery, we designed this multi-center clinical trial to compare the influence of LMA and ETI on PPCs. METHODS/DESIGN: In this multi-center, randomized, parallel clinical trial, a total of 6000 elderly patients, aged ≥ 70 years, with an American Society of Anesthesiologists classification level of 1–2 and a body mass index ≤ 35 kg/m(2), undergoing elective surgery will be enrolled and randomized into the LMA or the ETI group. Both groups will receive usual perioperative care except for the adoption of LMA/ETI. Primary outcomes are the occurrence of PPCs and patients’ perioperative mortality rates. Ease of intubation, anesthetics consumption, treatment for PPCs, duration of surgery, anesthesia recovery time and performance, time of PPC onset, postanesthesia care unit stay, intensive care unit admission and stay, in-hospital days, re-admission rates, hospitalization cost, and patients’ satisfactory scores will be secondary outcomes. Follow-up will be conducted through phone-call visits until 12 weeks after discharge. DISCUSSION: This trial will assess the possible benefits or disadvantages of perioperative LMA use in elderly patients compared with ETI regarding the occurrence of PPCs and clinical prognosis. We expect that this trial will also add to the current understanding of PPCs in geriatric populations and contribute to the international recommendations of geriatric surgery management. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02240901. Registered on 16 September 2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3351-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6505282 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-65052822019-05-10 Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial Zhu, Ling Shi, Xiao Yin, Suqing Yin, Jiemin Zhu, Ziyu Gao, Xiong Jiao, Yingfu Yu, Weifeng Yang, Liqun Trials Study Protocol BACKGROUND: With the increasing amount of geriatric surgery, it has become a great challenge for anesthesiologists to reduce the incidence of postoperative pulmonary complications (PPCs). The two most popular airway management methods, laryngeal mask airway (LMA) and endotracheal intubation (ETI), both have their unique advantages in specific clinical settings. For the purpose of helping clinicians make better decisions on airway management during geriatric surgery, we designed this multi-center clinical trial to compare the influence of LMA and ETI on PPCs. METHODS/DESIGN: In this multi-center, randomized, parallel clinical trial, a total of 6000 elderly patients, aged ≥ 70 years, with an American Society of Anesthesiologists classification level of 1–2 and a body mass index ≤ 35 kg/m(2), undergoing elective surgery will be enrolled and randomized into the LMA or the ETI group. Both groups will receive usual perioperative care except for the adoption of LMA/ETI. Primary outcomes are the occurrence of PPCs and patients’ perioperative mortality rates. Ease of intubation, anesthetics consumption, treatment for PPCs, duration of surgery, anesthesia recovery time and performance, time of PPC onset, postanesthesia care unit stay, intensive care unit admission and stay, in-hospital days, re-admission rates, hospitalization cost, and patients’ satisfactory scores will be secondary outcomes. Follow-up will be conducted through phone-call visits until 12 weeks after discharge. DISCUSSION: This trial will assess the possible benefits or disadvantages of perioperative LMA use in elderly patients compared with ETI regarding the occurrence of PPCs and clinical prognosis. We expect that this trial will also add to the current understanding of PPCs in geriatric populations and contribute to the international recommendations of geriatric surgery management. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02240901. Registered on 16 September 2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3351-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-05-08 /pmc/articles/PMC6505282/ /pubmed/31068221 http://dx.doi.org/10.1186/s13063-019-3351-2 Text en © The Author(s). 2019 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 | Study Protocol Zhu, Ling Shi, Xiao Yin, Suqing Yin, Jiemin Zhu, Ziyu Gao, Xiong Jiao, Yingfu Yu, Weifeng Yang, Liqun Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial |
title | Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial |
title_full | Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial |
title_fullStr | Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial |
title_full_unstemmed | Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial |
title_short | Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial |
title_sort | effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (polma-ep trial): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6505282/ https://www.ncbi.nlm.nih.gov/pubmed/31068221 http://dx.doi.org/10.1186/s13063-019-3351-2 |
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