Cargando…
The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial
BACKGROUND: Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124294/ https://www.ncbi.nlm.nih.gov/pubmed/27887662 http://dx.doi.org/10.1186/s13063-016-1699-0 |
_version_ | 1782469838492401664 |
---|---|
author | Kim, Eugene Yang, Seong Mi Yoon, So Jeong Bahk, Jae-Hyon Seo, Jeong-Hwa |
author_facet | Kim, Eugene Yang, Seong Mi Yoon, So Jeong Bahk, Jae-Hyon Seo, Jeong-Hwa |
author_sort | Kim, Eugene |
collection | PubMed |
description | BACKGROUND: Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes. METHODS/DESIGN: This is a prospective, double-blind, single-center, parallel-arm, noninferiority, randomized controlled trial to be conducted in participants aged 20–80 years who are undergoing elective surgery under general anesthesia with orotracheal intubation. Participants are randomly assigned into one of two groups depending on whether intubation is performed using a tracheal tube lubricated with water (n = 150) or without any pretreatment (n = 150). The primary outcome is the incidence of sore throat at 0, 2, 4, and 24 h after surgery, which is analyzed with a noninferiority test. The secondary outcomes are the incidence and severity of postoperative hoarseness, oropharyngeal injuries, and respiratory infections. DISCUSSION: Because we hypothesized that lubricating tracheal tubes using water has no advantage in reducing airway injuries associated with intubation, we will compare the incidence of sore throat, which is the most common complaint after intubation, in a noninferiority manner. This is the first randomized controlled trial to investigate the possibly beneficial or harmful effects of lubricating tracheal tubes using water before intubation. We expect that this trial will provide useful evidence to formulate a protocol for preparing tracheal tubes before intubation. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov on 1 July 2015 (NCT02492646) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1699-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5124294 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-51242942016-12-08 The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial Kim, Eugene Yang, Seong Mi Yoon, So Jeong Bahk, Jae-Hyon Seo, Jeong-Hwa Trials Study Protocol BACKGROUND: Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes. METHODS/DESIGN: This is a prospective, double-blind, single-center, parallel-arm, noninferiority, randomized controlled trial to be conducted in participants aged 20–80 years who are undergoing elective surgery under general anesthesia with orotracheal intubation. Participants are randomly assigned into one of two groups depending on whether intubation is performed using a tracheal tube lubricated with water (n = 150) or without any pretreatment (n = 150). The primary outcome is the incidence of sore throat at 0, 2, 4, and 24 h after surgery, which is analyzed with a noninferiority test. The secondary outcomes are the incidence and severity of postoperative hoarseness, oropharyngeal injuries, and respiratory infections. DISCUSSION: Because we hypothesized that lubricating tracheal tubes using water has no advantage in reducing airway injuries associated with intubation, we will compare the incidence of sore throat, which is the most common complaint after intubation, in a noninferiority manner. This is the first randomized controlled trial to investigate the possibly beneficial or harmful effects of lubricating tracheal tubes using water before intubation. We expect that this trial will provide useful evidence to formulate a protocol for preparing tracheal tubes before intubation. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov on 1 July 2015 (NCT02492646) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1699-0) contains supplementary material, which is available to authorized users. BioMed Central 2016-11-25 /pmc/articles/PMC5124294/ /pubmed/27887662 http://dx.doi.org/10.1186/s13063-016-1699-0 Text en © The Author(s). 2016 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 Kim, Eugene Yang, Seong Mi Yoon, So Jeong Bahk, Jae-Hyon Seo, Jeong-Hwa The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
title | The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
title_full | The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
title_fullStr | The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
title_full_unstemmed | The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
title_short | The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
title_sort | effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124294/ https://www.ncbi.nlm.nih.gov/pubmed/27887662 http://dx.doi.org/10.1186/s13063-016-1699-0 |
work_keys_str_mv | AT kimeugene theeffectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT yangseongmi theeffectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT yoonsojeong theeffectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT bahkjaehyon theeffectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT seojeonghwa theeffectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT kimeugene effectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT yangseongmi effectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT yoonsojeong effectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT bahkjaehyon effectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial AT seojeonghwa effectsofwaterlubricationoftrachealtubesonpostintubationairwaycomplicationsstudyprotocolforarandomizedcontrolledtrial |