Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 5:46 AM
Study NCT ID:
NCT07077733
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Postoperative Sore Throat Following Endotracheal Intubation Performed With Videolaryngoscope, Videostylet, and Fiberoptic Bronchoscope
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
Comparison of Postoperative Sore Throat Following Endotracheal Intubation Performed With Videolaryngoscope, Videostylet, and Fiberoptic Bronchoscope
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: