NCT07309978

Brief Summary

This prospective observational study aims to evaluate whether upper airway ultrasound measurements can improve the prediction of difficult airway compared with conventional anthropometric assessments. Adult patients undergoing elective procedures requiring airway management will be included. Ultrasound parameters such as tongue thickness, anterior neck soft tissue thickness, and hyomental distance will be measured before airway intervention. Standard clinical predictors (Mallampati score, thyromental distance, neck circumference, etc.) will also be recorded. The primary objective is to determine the diagnostic accuracy of ultrasound-based measurements in predicting difficult laryngoscopy and intubation. The study seeks to provide evidence supporting the integration of upper airway ultrasound into routine pre-anesthetic airway evaluation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
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 Progress18%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

December 16, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

December 16, 2025

Last Update Submit

March 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of ultrasound airway measurements for predicting difficult mask ventilation

    Evaluation of the sensitivity, specificity, and area under the ROC curve (AUC) of ultrasound-based airway measurements-tongue thickness, hyoid-to-skin distance, and epiglottis-to-skin distance-in predicting difficult mask ventilation. These ultrasound parameters will be compared with conventional anthropometric airway assessment tests to determine their predictive performance.

    Preoperative assessment (within 1 hour before induction of anesthesia)

Study Arms (1)

Single Cohort

This cohort includes all adult participants undergoing airway evaluation with upper airway ultrasound and standard anthropometric measurements. No interventions are applied; participants are observed prospectively to assess the predictive value of ultrasound parameters for difficult airway.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients (18-99 years) scheduled for elective surgery under general anesthesia at a tertiary care hospital. Participants represent typical surgical patients requiring preoperative airway assessment. No healthy volunteers will be enrolled. Only ASA I-III patients who can provide informed consent will be included.

You may qualify if:

  • Adults aged 18-99 years
  • Patients scheduled for elective surgery under general anesthesia
  • ASA Physical Status I-III
  • Able to provide informed consent
  • Undergoing preoperative airway evaluation

You may not qualify if:

  • \- Emergency surgery cases
  • Age \<18 years
  • ASA Physical Status IV-V
  • Pregnant or breastfeeding patients
  • Patients with limited cooperation or inability to provide consent
  • Known anatomical airway anomalies or previous major neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Rastogi A, Singh AK, Srivastava D, Kannaujia AK, Singh TK, Mishra P. Evaluation of ultrasound measured tongue thickness, tongue thickness-thyromental distance ratio, and skin-to-epiglottis distance in predicting unanticipated difficult laryngoscopy. J Anaesthesiol Clin Pharmacol. 2025 Jan-Mar;41(1):151-157. doi: 10.4103/joacp.joacp_423_23. Epub 2025 Jan 23.

    PMID: 40026745BACKGROUND
  • Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051.

    PMID: 28403413BACKGROUND
  • Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Airway physical examination tests for detection of difficult airway management in apparently normal adult patients. Cochrane Database Syst Rev. 2018 May 15;5(5):CD008874. doi: 10.1002/14651858.CD008874.pub2.

    PMID: 29761867BACKGROUND

Study Design

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

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

December 25, 2025

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

December 25, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations