Skip to content

Effect of Colding of Endotracheal Tubes on Sore Throat

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05834179
Enrollment
116
Registered
2023-04-28
Start date
2023-04-15
Completion date
2023-09-20
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sore Throat

Keywords

endotracheal tube, sore throat, dysphagia

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.

Interventions

OTHERcold endotracheal tube

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

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
the incidence of sore throat 4 hour after extubation.4 hour after extubationPresence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
the severity of sore throat 4 hour after extubation.4 hour after extubationSeverity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the incidence of sore throat 12 hour after extubation.12 hour after extubationPresence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
the severity of sore throat 12 hour after extubation.12 hour after extubationSeverity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the severity of sore throat 1 hour after extubation.1 hour after extubationSeverity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the severity of sore throat 24 hour after extubation.24 hour after extubationSeverity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
the incidence of dysphonia1 hour after extubationPresence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
the incidence of dysphagia12 hour after extubationPresence of dysphagia defined as difficulty or pain provoked by swallowing
the incidence of postoperative respiratory infection7 days after operationPresence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever
the incidence of sore throat 24 hour after extubation.24 hour after extubationPresence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026