NCT07077733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

June 28, 2025

Last Update Submit

July 11, 2025

Conditions

Keywords

videolaryngoscopevideostyletfiberoptic bronchoscopepostoperative sore throat

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • intubation time

    from the beginning to the end of the intubation procedure

  • first-attempt success rate

    from the beginning to the end of the intubation procedure

  • hemodynamic responses to intubation

    from the beginning to the end of the intubation procedure

  • complications during the intubation

    from the beginning to the end of the intubation procedure

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Üniversitesi

Ankara, altındağ, 06230, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiology resident

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 22, 2025

Study Start

January 1, 2023

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations