NCT07366177

Brief Summary

Patient safety is the cornerstone of anesthetic practice, and maintaining adequate respiration represents its most critical initial step. In situations where spontaneous breathing cannot be sustained-such as during general anesthesia-the airway must be mechanically secured. While simple face masks may be sufficient in some cases, endotracheal intubation remains the most reliable method for airway control in conditions associated with respiratory depression. Airway management may be challenging due to various patient-related anatomical factors, including facial and mandibular structure, obesity, limited mouth opening, facial hair, sunken cheeks, wide facial morphology, and a short or muscular neck. These challenges are collectively described as difficult ventilation and difficult intubation (cannot ventilate-cannot intubate), which may occur unexpectedly or be anticipated. A difficult airway is defined as difficulty encountered by a trained anesthesiologist in face mask ventilation, tracheal intubation, or both. Several predictors of difficult airway are widely accepted, such as thyromental and sternomental distances, neck circumference, Mallampati classification, upper lip bite test, mouth opening, and interincisor distance. Thorough preoperative airway evaluation is mandatory, as difficult mask ventilation and failed intubation remain major contributors to anesthesia-related morbidity and mortality. Although numerous studies have examined these predictors, research focusing on facial morphology and anthropometric indices-particularly the face index-is extremely limited. Facial morphology varies considerably among individuals and can be evaluated anthropometrically using simple, noninvasive tools such as a digital caliper. Anthropometric analysis is commonly applied in forensic medicine and reconstructive surgery but has rarely been incorporated into airway assessment. This study aims to introduce face index analysis as a novel predictor of difficult airway alongside conventional methods. By evaluating measurements such as trichion-gnathion distance, total facial index, upper facial index, and nasal index, the study investigates whether airway difficulty can be predicted using a single index value. All measurements are standard, noninvasive, and routinely performed during preoperative assessment.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Mar 2026

Shorter than P25 for all trials

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 Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

Keywords

Difficult airway, face index, anesthesia

Outcome Measures

Primary Outcomes (1)

  • Face index and face mask ventilation

    Face index is useful measurement about difficult laryngoscopy management in anesthesia

    365 days

Secondary Outcomes (1)

  • Face index and intubation

    365 days

Interventions

Face index is an anthropometric measurement

Eligibility Criteria

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

All patients over 18 years of age who will undergo general anesthesia and intubation

You may qualify if:

  • All adult patients over the age of 18 who have given written consent to undergo elective and/or emergency surgery under general anesthesia and be intubated in the operating rooms of our hospital's main building and annex building

You may not qualify if:

  • Patients with a prior history of difficult airway/difficult intubation, those who have undergone facial, neck, or airway surgery, those with deformities or scars in the facial and neck area due to burns or injuries, those with previous or recent tracheostomy, those with facial deformities due to any cause (congenital or acquired pathologies), and those with communication problems and who are uncooperative during measurements will be excluded from the study. Children and pregnant patients will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.

  • Coskun A, Duzgun SA, Bozer M, Akinci OF, Uzunkoy A. Modified technique for correction of gynaecomastia. Eur J Surg. 2001 Nov;167(11):822-4. doi: 10.1080/11024150152717643.

  • Jackson JS, Rondeau B. Mallampati Score. 2025 Jul 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK585119/

  • Chow HH, Tolle KM, Roe DJ, Elsberry V, Chen H. Application of neural networks to population pharmacokinetic data analysis. J Pharm Sci. 1997 Jul;86(7):840-5. doi: 10.1021/js9604016.

  • Garber DA, Beverley SM, Coen DM. Demonstration of circularization of herpes simplex virus DNA following infection using pulsed field gel electrophoresis. Virology. 1993 Nov;197(1):459-62. doi: 10.1006/viro.1993.1612.

  • Vidon N, Palma R, Bernier JJ. [Water-electrolyte movements along the human intestine in diarrhea induced by mannitol]. Gastroenterol Clin Biol. 1983 Jan;7(1):23-9. No abstract available. French.

Study Officials

  • Nilay Taş, Prof. Dr.

    Ordu University School of Medicine, Türkiye

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasir İlyas, Ass. Prof.

CONTACT

Halil Yılmaz, Ass. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share