Comparison of Postoperative Sore Throat Following Endotracheal Intubation Performed With Videolaryngoscope, Videostylet, and Fiberoptic Bronchoscope

NCT ID: NCT07077733

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 311 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-06-01

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.

Conditions

Postoperative Sore Throat

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Video laryngoscopy

Patients who underwent intubation using a videolaryngoscope

No interventions assigned to this group

Video stylet

Patients who underwent intubation using a video stylet

No interventions assigned to this group

Fiberoptic bronchoscopy

Patients who underwent intubation using fiberoptic bronchoscopy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The requirement for endotracheal intubation for general anesthesia during elective surgery in our hospital
• Being between 18 and 65 years of age
• Having an ASA physical status classification of I or II
• Providing informed consent to participate in the study

Exclusion Criteria

• Presence of a coagulation disorder
• Being identified as a patient with a predicted difficult airway (Patients anticipated to have a difficult airway during standard preoperative anesthesia evaluation and documented as such in the preoperative assessment notes. Relevant criteria include: Mallampati score of 3 or 4, upper lip bite test grade 3, short neck length, abnormal neck anatomy or limited neck mobility, micrognathia/retrognathia, facial deformities/trauma, and mouth opening less than 3 cm.)
• Presence of obesity (body mass index > 35 kg/m²)
• Undergoing head and neck surgery in which postoperative sore throat is expected due to the surgical site
• Placement of a nasogastric (NG) tube during surgery, which may contribute to postoperative sore throat
• Refusal to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

ayşe meryem yalçın

anesthesiology resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe Üniversitesi

Ankara, altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA-23060

Identifier Type: -

Identifier Source: org_study_id