Effect of Colding of Endotracheal Tubes on Sore Throat

Postoperative Sore Throat Clinical Trial

Official title:

Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834179
• Other study ID #: KA 23-42
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: May 7, 2023

Study information

• Verified date: April 2023
• Source: Baskent University
• Contact: sibel çatalca, dr.
• Phone: 90 322 327 27 27
• Email: drsibelcatalca[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: May 7, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Sore Throat

Intervention

Other:
• cold endotracheal tube
patients who were intubated with an ETT which kept in the fridge.

Locations

Country	Name	City	State
Turkey	Baskent University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 hour after extubation
Secondary	the incidence of sore throat 4 hour after extubation.	Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)	4 hour after extubation
Secondary	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	4 hour after extubation
Secondary	the incidence of sore throat 12 hour after extubation.	Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)	12 hour after extubation
Secondary	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	12 hour after extubation
Secondary	the incidence of sore throat 24 hour after extubation.	Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)	24 hour after extubation
Secondary	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	24 hour after extubation
Secondary	the incidence of dysphonia	Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)	1 hour after extubation
Secondary	the incidence of dysphonia	Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)	4 hour after extubation
Secondary	the incidence of dysphonia	Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)	12 hour after extubation
Secondary	the incidence of dysphonia	Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)	24 hour after extubation
Secondary	the incidence of dysphagia	Presence of dysphagia defined as difficulty or pain provoked by swallowing	12 hour after extubation
Secondary	the incidence of dysphagia	Presence of dysphagia defined as difficulty or pain provoked by swallowing	24 hour after extubation
Secondary	the incidence of postoperative respiratory infection	Presence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever	7 days after operation

External Links

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