NCT05834179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

April 2, 2023

Last Update Submit

September 5, 2025

Conditions

Postoperative Sore Throat

Keywords

endotracheal tubesore throatdysphagia

Outcome Measures

Primary Outcomes (1)

  • the incidence of sore throat 1 hour after extubation.

    Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

    1 hour after extubation

Secondary Outcomes (14)

  • the severity of sore throat 1 hour after extubation.

    1 hour after extubation

  • the incidence of sore throat 4 hour after extubation.

    4 hour after extubation

  • the severity of sore throat 4 hour after extubation.

    4 hour after extubation

  • the incidence of sore throat 12 hour after extubation.

    12 hour after extubation

  • the severity of sore throat 12 hour after extubation.

    12 hour after extubation

  • +9 more secondary outcomes

Study Arms (2)

cold endotracheal tube (ETT)

EXPERIMENTAL

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

Other: cold endotracheal tube

Endotracheal tube (ETT) in the normal temperature

NO INTERVENTION

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

Interventions

cold endotracheal tubeOTHER

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

cold endotracheal tube (ETT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Adana, Adana, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32926423BACKGROUND

  • 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.

    PMID: 30286145BACKGROUND

Related Links

MeSH Terms

Conditions

PharyngitisDeglutition Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • sibel çatalca, dr.

    Baskent University Adana Dr. Turgut Noyan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 28, 2023

Study Start

April 15, 2023

Primary Completion

September 15, 2023

Study Completion

September 20, 2023

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)