NCT07383610

Brief Summary

Difficult airway management is a major cause of perioperative complications. Standard bedside airway assessment tests may have limited ability to predict difficult intubation and difficult mask ventilation. This prospective observational study aims to evaluate whether preoperative ultrasound measurements of airway structures (such as skin-to-epiglottis distance, tongue thickness, and pre-epiglottic space) can predict difficult intubation and difficult mask ventilation in adult patients undergoing surgery under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 26, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Airway UltrasonographyUltrasoundDifficult Airway PredictionAnesthesia

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Difficult Intubation

    Difficult intubation was defined as requiring two or more intubation attempts (≥2 attempts) during induction of general anesthesia.

    During induction of anesthesia (intraoperative)

  • Number of Participants with Difficult Mask Ventilation

    Difficult mask ventilation was defined as the need for two-handed mask ventilation or inability to ventilate adequately using a face mask

    During induction of anesthesia (intraoperative)

Study Arms (1)

Cohort 1: Adult patients undergoing surgery under general anesthesia

Adult patients (18-70 years, ASA I-III) scheduled for elective surgery under general anesthesia requiring orotracheal intubation. Preoperative clinical airway assessment and ultrasonographic airway measurements were recorded, and intraoperative intubation and mask ventilation outcomes were evaluated

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-70 years (ASA I-III) scheduled for elective surgery under general anesthesia requiring orotracheal intubation

You may qualify if:

  • Age 18-70 years
  • ASA physical status I-III
  • Elective surgery under general anesthesia requiring orotracheal intubation
  • Written informed consent

You may not qualify if:

  • Refusal to participate
  • Emergency surgery
  • Pregnancy
  • Known upper airway pathology or previous airway surgery
  • Restricted mouth opening (\<3 cm)
  • Cervical spine instability or significant limitation of neck mobility
  • Morbid obesity (BMI ≥40 kg/m²)
  • Obstructive upper airway masses (e.g., head and neck tumors)
  • Prior neck radiotherapy
  • Clinically relevant neck masses
  • Major facial/mandibular trauma or craniofacial anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Kütahya, 3100, Turkey (Türkiye)

Location

Related Publications (1)

  • 1. Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012;109 Suppl 1(suppl 1):i68-i85. 2. Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, et al. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022;136(1):31-81. 3. Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, et al. Airway physical examination tests for detection of difficult airway management in apparently normal adult patients. Cochrane Database Syst Rev. 2018;5(5):CD008874. 4. Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005;103(2):429-37. 5. Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, et al. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019;321(5):493-503. 6. Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E. Use of sonography for airway assessment: an observational study. J Ultrasound Med. 2010;29(1):79-85. 7. Kundra P, Mishra SK, Ramesh A. Ultrasound of the airway. Indian J Anaesth. 2011;55(5):456-62. 8. Marchis IF, Negrut MF, Blebea CM, Crihan M, Alexa AL, Breazu CM. Trends in Preoperative Airway Assessment. Diagnostics (Basel). 2024;14(6). 9. Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017;118(4):601-9. 10. Daggupati H, Maurya I, Singh RD, Ravishankar M. Development of a scoring system for predicting difficult intubation using ultrasonography. Indian J Anaesth. 2020;64(3):187-92. 11. Sotoodehnia M, Khodayar M, Jalali A, Momeni M, Safaie A, Abdollahi A. Prediction of difficult laryngoscopy / difficult intubation cases using upper airway ultrasound measurements in emergency department: a prospective observational study. BMC Emerg Med. 2023;23(1):78

    RESULT

Study Officials

  • Serkan Telli, MD

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies and to protect participant privacy and confidentiality.

Locations