search
Back to results

Effect of Colding of Endotracheal Tubes on Sore Throat

Primary Purpose

Postoperative Sore Throat

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cold endotracheal tube
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Sore Throat focused on measuring endotracheal tube, sore throat, dysphagia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baskent UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cold endotracheal tube (ETT)

Endotracheal tube (ETT) in the normal temperature

Arm Description

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

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

Outcomes

Primary Outcome Measures

the incidence of sore throat 1 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

Secondary Outcome Measures

the severity of sore throat 1 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the incidence of sore throat 4 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
the severity of sore throat 4 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the incidence of sore throat 12 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
the severity of sore throat 12 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the incidence of sore throat 24 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
the severity of sore throat 24 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
the incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
the incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
the incidence of postoperative respiratory infection
Presence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever

Full Information

First Posted
April 2, 2023
Last Updated
April 17, 2023
Sponsor
Baskent University
search

1. Study Identification

Unique Protocol Identification Number
NCT05834179
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat
Keywords
endotracheal tube, sore throat, dysphagia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cold endotracheal tube (ETT)
Arm Type
Experimental
Arm Description
Patients who were intubated with an ETT which kept in the fridge.
Arm Title
Endotracheal tube (ETT) in the normal temperature
Arm Type
No Intervention
Arm Description
Patients who were intubated with an ETT which kept in the operation room.
Intervention Type
Other
Intervention Name(s)
cold endotracheal tube
Intervention Description
patients who were intubated with an ETT which kept in the fridge.
Primary Outcome Measure Information:
Title
the incidence of sore throat 1 hour after extubation.
Description
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time Frame
1 hour after extubation
Secondary Outcome Measure Information:
Title
the severity of sore throat 1 hour after extubation.
Description
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time Frame
1 hour after extubation
Title
the incidence of sore throat 4 hour after extubation.
Description
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time Frame
4 hour after extubation
Title
the severity of sore throat 4 hour after extubation.
Description
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time Frame
4 hour after extubation
Title
the incidence of sore throat 12 hour after extubation.
Description
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time Frame
12 hour after extubation
Title
the severity of sore throat 12 hour after extubation.
Description
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time Frame
12 hour after extubation
Title
the incidence of sore throat 24 hour after extubation.
Description
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Time Frame
24 hour after extubation
Title
the severity of sore throat 24 hour after extubation.
Description
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Time Frame
24 hour after extubation
Title
the incidence of dysphonia
Description
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time Frame
1 hour after extubation
Title
the incidence of dysphonia
Description
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time Frame
4 hour after extubation
Title
the incidence of dysphonia
Description
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time Frame
12 hour after extubation
Title
the incidence of dysphonia
Description
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Time Frame
24 hour after extubation
Title
the incidence of dysphagia
Description
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Time Frame
12 hour after extubation
Title
the incidence of dysphagia
Description
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Time Frame
24 hour after extubation
Title
the incidence of postoperative respiratory infection
Description
Presence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever
Time Frame
7 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sibel çatalca, dr.
Phone
90 322 327 27 27
Ext
11467
Email
drsibelcatalca@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sibel çatalca, dr.
Organizational Affiliation
Baskent University Adana Dr. Turgut Noyan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sibel catalca, specialist
Email
drsibelcatalca@gmail.com
First Name & Middle Initial & Last Name & Degree
sibel catalca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32926423
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.
Results Reference
background
PubMed Identifier
30286145
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32926423/
Description
article
URL
https://pubmed.ncbi.nlm.nih.gov/30286145/
Description
article2

Learn more about this trial

Effect of Colding of Endotracheal Tubes on Sore Throat

We'll reach out to this number within 24 hrs