Effect of Colding of Endotracheal Tubes on Sore Throat

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Sore Throat

Intervention / Treatment
-----------------
* Other: cold endotracheal tube


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cold endotracheal tube (ETT)<br>Patients who were intubated with an ETT which kept in the fridge. | Other: cold endotracheal tube<br>* patients who were intubated with an ETT which kept in the fridge.<br>|
| No Intervention: Endotracheal tube (ETT) in the normal temperature<br>Patients who were intubated with an ETT which kept in the operation room. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| the incidence of dysphonia | Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes) | 1 hour after extubation | 
| the incidence of dysphonia | Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes) | 4 hour after extubation | 
| the incidence of dysphonia | Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes) | 12 hour after extubation | 
| the incidence of dysphonia | Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes) | 24 hour after extubation | 
| the incidence of dysphagia | Presence of dysphagia defined as difficulty or pain provoked by swallowing | 12 hour after extubation | 
| the incidence of dysphagia | Presence of dysphagia defined as difficulty or pain provoked by swallowing | 24 hour after extubation | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal tube, sore throat, dysphagia