NCT07355608

Brief Summary

Background: Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation. Objectives: This study aims to:

  1. 1.Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways.
  2. 2.Create a glottic view scoring system specifically tailored to videolaryngoscopy.
  3. 3.Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
4,977

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

December 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 2, 2025

Last Update Submit

February 3, 2026

Conditions

Airway Management

Keywords

Airway managementVideolaryngoscopeDifficult airway

Outcome Measures

Primary Outcomes (5)

  • Failed first intubation attempt

    Failed to intubate at firtst attempt

    2 minutes after anesthesia induction

  • Difficult intubation

    Failed to intubate at 1-2 attempts and/or intubation duration longer than 120 second

    2 minutes after anesthesia induction

  • Failed intubation

    Not able to intubate the patient

    2 minutes after anesthesia induction

  • Intubation duration

    Time elapsed from entring the blade between the teeth to detecting an entidal carbondioxide trace

    2 minutes after anesthesia induction

  • Glottic view description

    Vocal cords are fully visible Vocal cords are partially separately Vocal cords are not visible Cords are adducted Epiglottis is visible Epiglottis is large Epiglottis is small Epiglottis is edematous Epiglottis mass is present Arytenoids are visible Arytenoid luxation or subluxation Arytenoid edema Valecula problem (edema, Coffee grounds, etc., unable to insert a blade) Aryepiglottic plica pathology (edema, Coffee grounds scar) Laryngeal structures should be formed Glottic stenosis Laryngospasm

    2 minutes after anesthesia induction

Secondary Outcomes (2)

  • Percentil of glottic opening score

    2 minutes after anesthesia induction

  • Cormack lehanne score

    2 minutes after anesthesia induction

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults, both with normal or predicted difficult airways, undergoing orotracheal intubation with a videolarygoscope, for a case mix of surgeries

You may qualify if:

  • Adults
  • Both with normal or predicted difficult airways
  • Undergoing orotracheal intubation with a videolarygoscope

You may not qualify if:

  • Rapid sequence intubation
  • Double lumen tube intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Location

Related Publications (2)

  • Xia M, Jin C, Zheng Y, Wang J, Zhao M, Cao S, Xu T, Pei B, Irwin MG, Lin Z, Jiang H. Deep learning-based facial analysis for predicting difficult videolaryngoscopy: a feasibility study. Anaesthesia. 2024 Apr;79(4):399-409. doi: 10.1111/anae.16194. Epub 2023 Dec 13.

    PMID: 38093485BACKGROUND

  • O'Loughlin EJ, Swann AD, English JD, Ramadas R. Accuracy, intra- and inter-rater reliability of three scoring systems for the glottic view at videolaryngoscopy. Anaesthesia. 2017 Jul;72(7):835-839. doi: 10.1111/anae.13837. Epub 2017 Mar 24.

    PMID: 28337769BACKGROUND

Study Officials

  • Dilek Yazıcıoğlu Ünal, professor

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Yazıcıoğlu Ünal, Professor

CONTACT

+90 5336957855dilekunalmd@gmail.com

Emel Gündüz, assoc.

CONTACT

+905444341719dregunduz@hotmail.com,

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

December 2, 2025

First Posted

January 21, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)