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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial

Authors: Eugene Kim, Seong Mi Yang, So Jeong Yoon, Jae-Hyon Bahk, Jeong-Hwa Seo

Published in: Trials | Issue 1/2016

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Abstract

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)
Appendix
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Metadata
Title
The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial
Authors
Eugene Kim
Seong Mi Yang
So Jeong Yoon
Jae-Hyon Bahk
Jeong-Hwa Seo
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1699-0

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