Postoperative Sore Throat Clinical Trial
Official title:
Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study
NCT number | NCT05834179 |
Other study ID # | KA 23-42 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2023 |
Est. completion date | May 7, 2023 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Baskent University | Adana |
Lead Sponsor | Collaborator |
---|---|
Baskent University |
Turkey,
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
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 |
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