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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Sore Throat

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.

• Study Type: Observational
• Enrollment (Actual): 311

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06230
      • Hacettepe Universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 18 and 65 years with an ASA physical status score of I or II, who underwent elective surgery under general anesthesia at the operating rooms of Hacettepe University Hospital, were enrolled.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Video laryngoscopy; Patients who underwent intubation using a videolaryngoscope
Video stylet; Patients who underwent intubation using a video stylet
Fiberoptic bronchoscopy; Patients who underwent intubation using fiberoptic bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative sore throat and hoarseness	Primary aim of this study is to compare video laryngoscope (VL), video stylet (VS) and fiberoptic bronchoscope (FOB) devices in patients without anticipated difficult airway undergoing elective intubation, in terms of postoperative sore throat and hoarseness at the 20th minute and 6th hour postoperatively.	6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation time	The duration between the placement of the airway device, selected by the attending anesthesiologist, into the patient's mouth and the confirmation of successful intubation (as indicated by the appearance of end-tidal CO₂ on the capnograph) was recorded as the intubation time.	from the beginning to the end of the intubation procedure
first-attempt success rate	The success of intubation with the selected airway device on the first attempt was recorded; in cases where the first attempt failed, the total number of intubation attempts was noted.	from the beginning to the end of the intubation procedure
hemodynamic responses to intubation	The patient's hemodynamic changes during intubation were noted	from the beginning to the end of the intubation procedure
complications during the intubation	Complications during intubation were noted	from the beginning to the end of the intubation procedure

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: June 28, 2025
• First Submitted That Met QC Criteria: July 11, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: videolaryngoscope; postoperative sore throat; fiberoptic bronchoscope; videostylet
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis
• Other Study ID Numbers: KA-23060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No