Clinical trial NCT05834179: Effect of Colding of Endotracheal Tubes on Sore Throat
Official title: Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Sore Throat
Keywords: endotracheal tube
sore throat
dysphagia
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.

Detailed description: The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia.It is an undesirable events experienced by patients after general anaesthesia. Various pharmacological agents have been applied to reduce POST, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. However, these agents may have some systemic and local side effects. Therefore, various non-pharmacological applications have been investigated to reduce sore throat. Cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. Although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. Therefore, we hypothesized that colding of endotracheal tube may decrease POST associated with airway inflammation. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. This study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.

Eligibility criteria: Inclusion Criteria:

Patients who were entubated with an ETT. Those who accept the research Elective surgery Patients in American Society of Anaesthesiologists (ASA) I and II class 18 years and over Mallampati classification I and II Operation time more than 1 hour

Exclusion Criteria:

Patients with sore throat and lower respiratory tract infection Patients with a history of allergies

Primary outcomes:
measure: the incidence of sore throat 1 hour after extubation.
timeFrame: 1 hour after extubation
Secondary outcomes:
measure: the severity of sore throat 1 hour after extubation.
timeFrame: 1 hour after extubation
measure: the incidence of sore throat 4 hour after extubation.
timeFrame: 4 hour after extubation
measure: the severity of sore throat 4 hour after extubation.
timeFrame: 4 hour after extubation
measure: the incidence of sore throat 12 hour after extubation.
timeFrame: 12 hour after extubation
measure: the severity of sore throat 12 hour after extubation.
timeFrame: 12 hour after extubation
measure: the incidence of sore throat 24 hour after extubation.
timeFrame: 24 hour after extubation
measure: the severity of sore throat 24 hour after extubation.
timeFrame: 24 hour after extubation
measure: the incidence of dysphonia
timeFrame: 1 hour after extubation
measure: the incidence of dysphonia
timeFrame: 4 hour after extubation
measure: the incidence of dysphonia
timeFrame: 12 hour after extubation
measure: the incidence of dysphonia
timeFrame: 24 hour after extubation
measure: the incidence of dysphagia
timeFrame: 12 hour after extubation
measure: the incidence of dysphagia
timeFrame: 24 hour after extubation
measure: the incidence of postoperative respiratory infection
timeFrame: 7 days after operation
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University
Study officials:
affiliation: Baskent University Adana Dr. Turgut Noyan Hospital
name: sibel çatalca, dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu JH, Paik HS, Ryu HG, Lee H. Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):213-219. doi: 10.1111/aas.13705. Epub 2020 Sep 23.
citation: Kim E, Yang SM, Kwak SG, Park S, Bahk JH, Seo JH. Tracheal tubes lubricated with water to reduce sore throat after intubation: A randomized non-inferiority trial. PLoS One. 2018 Oct 4;13(10):e0204846. doi: 10.1371/journal.pone.0204846. eCollection 2018.