Loading clinical trials...
Loading clinical trials...
This study aims to compare video laryngoscope (VL), video stylet (VS), and fiberoptic bronchoscope (FOB) in elective endotracheal intubations of patients aged 18 to 65 years, classified as ASA I-II and without predicted difficult airways. The primary endpoints are the incidence of postoperative sore throat and hoarseness, while secondary endpoints include intubation time, first-attempt intubation success, hemodynamic responses, and procedure-related complications. Postoperative sore throat and hoarseness will be assessed at the bedside at the 20th minute and 6th hour following extubation.
Objective: The selection of an appropriate device for endotracheal intubation is essential for successful airway management. Although various publications in the literature compare the techniques used for intubation in terms of their advantages and disadvantages, there remains a lack of consensus regarding the superiority of one method over another. This study aims to compare video laryngoscope (VL), video stylet (VS) and fiberoptic bronchoscope (FOB) devices in patients without anticipated difficult airway undergoing elective intubation, primarily in terms of postoperative sore throat and hoarseness, and secondarily in terms of intubation time, first-attempt success rate, hemodynamic responses, and complications. Materials and Methods: The study included patients aged 18-65 years, with ASA physical status I-II, who underwent elective surgery under general anesthesia at the operating rooms of Hacettepe University Hospitals, and who had no predictors of a difficult airway. Patients were allocated into three groups: Group VL (n=105) was intubated using the iS3-L Video Laryngoscope (Shenzhen Insighters Medical Technology, Gaung Dong, China); Group VS (n=102) using the iS3-R Video Rigid Stylet (Shenzhen Insighters Medical Technology, Gaung Dong, China); and Group FOB (n=104) using the iS3-C Video Flexible Laryngoscope (Shenzhen Insighters Medical Technology, Gaung Dong, China). The primary outcome was the incidence of postoperative sore throat and hoarseness at the 20th minute and 6th hour postoperatively. Secondary outcomes included intubation time, first-attempt success rate, hemodynamic responses to intubation, and complications during the procedure. Sample size calculations were performed using the G\*Power 3.1.9.6 (Franz Faul, Universität Kiel, Kiel, Germany) software. To detect at least a 20% difference in the incidence of postoperative sore throat between any two groups with 80% power and a 5% significance level, the required total sample size was calculated as 294 patients. However, accounting for potential exclusions and data loss, a minimum of 102 patients per group was targeted. This was a non-randomized, comparative clinical study. The anesthesiologist responsible for each case was not interfered with regarding the management of general anesthesia or the method of endotracheal tube insertion.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Hacettepe Üniversitesi
Ankara, altındağ, Turkey (Türkiye)
Start Date
January 1, 2023
Primary Completion Date
April 1, 2025
Completion Date
June 1, 2025
Last Updated
July 22, 2025
311
ACTUAL participants
Lead Sponsor
Hacettepe University
NCT07341646
NCT07088224
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05436743