Effect of Colding of Endotracheal Tubes on Sore Throat

NCT ID: NCT05834179

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2023-09-20

Brief Summary

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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

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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.

Conditions

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Postoperative Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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cold endotracheal tube (ETT)

Patients who were intubated with an ETT which kept in the fridge.

Group Type EXPERIMENTAL

cold endotracheal tube

Intervention Type OTHER

patients who were intubated with an ETT which kept in the fridge.

Endotracheal tube (ETT) in the normal temperature

Patients who were intubated with an ETT which kept in the operation room.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cold endotracheal tube

patients who were intubated with an ETT which kept in the fridge.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Sibel Catalca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sibel çatalca, dr.

Role: PRINCIPAL_INVESTIGATOR

Baskent University Adana Dr. Turgut Noyan Hospital

Locations

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Baskent University

Adana, Adana, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32926423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30286145 (View on PubMed)

Related Links

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Other Identifiers

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KA 23-42

Identifier Type: -

Identifier Source: org_study_id

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