NCT06928402

Brief Summary

Evaluating the success of measurements taken with ultrasound airway imaging in predicting difficult intubation by comparing conventional parameters in terms of difficult intubation and the proportion of patients encountered during intubation and characterised as difficult.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

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

First Submitted

Initial submission to the registry

April 8, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

April 8, 2025

Last Update Submit

September 14, 2025

Conditions

Keywords

airway managementairway ultrasounddifficult intubationdifficult ventilation

Outcome Measures

Primary Outcomes (1)

  • Ratio of ultrasound-derived parameters with conventional parameters

    ultrasound derived parameters: hyoid bone visibility, skin-hyoid distance, skin-hyoid distance, skin-crricothyroid membrane distance, cricothyroid membrane length and hyomental distance measured in neutral and extension and the ratio of these values. Conventional parameters: thyromental distance, sternomental distance, upper lip bite test, head-neck movement, presence of retrognathia, neck circumference, maximum mouth opening, Wilson difficult intubation score, Han scale and Mallampati score

    1 hour peroperatively

Secondary Outcomes (2)

  • Incidence of difficult intubation

    1 hour peroperatively

  • Incidence of difficult ventilation

    1 hour preoperatively

Study Arms (1)

Airway Measurement Group

As this study is observational in nature, no interventions will be performed by the research team. The study will ,nvolve a single group, within which the incidence and prevalence of the outcomes will be assessed.

Other: No intervention

Interventions

no interventions will be performed by the research team

Airway Measurement Group

Eligibility Criteria

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

All cases that meet the inclusion and exclusion criteria will be included in the study. Patients will be taken to the operating room after being preoperatively evaluated in the observation room. The patient's anesthetic management will be provided by another anesthesiologist who is not participating in the study and is responsible for the patient. Intraoperative data will be obtained from the patient's anaesthesia follow-up form and the records of the anaesthesia machine. This group will include patients who will be intubated and operated on under general anaesthesia.

You may qualify if:

  • Patients to be operated with endotracheal intubation under elective conditions
  • Voluntary patients whose informed consent was obtained,
  • Patients older than 18 years
  • Patients evaluated in the 1-2-3 category of the American Society of Anaesthesiologist (ASA)

You may not qualify if:

  • Patients with a history of difficult intubation
  • Pregnant patients
  • Patients with a history of surgery in the head and neck region
  • Patients with a history of trauma or tumour in the head and neck region
  • Presence of a syndrome that will cause difficult intubation
  • Uncooperative patients,
  • Patients with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Ataturk Sanatorium Research and Training Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Münire Babayiğit, MD

    Ankara Ataturk Sanatorium Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 15, 2025

Study Start

April 14, 2025

Primary Completion

August 31, 2025

Study Completion

September 10, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations