NCT05207254

Brief Summary

Although there is no related research on the evaluation of difficult airways by ultrasound features based on artificial intelligence, the investigators guess that the evaluation of ultrasound features based on artificial intelligence can make further breakthroughs in difficult airway early warning systems. Therefore, this project intends to use AI technology to extract and analyze the ultrasound features of the subjects, evaluate the correlation between the ultrasound features of the subjects and the occurrence of difficult airways, and construct possible diagnostic models to evaluate AI ultrasound feature recognition in the prediction of difficult airways. The effect and application value of this method are expected to be more intelligent and accurate for early warning of difficult airways in clinical anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 13, 2022

Status Verified

December 1, 2021

Enrollment Period

4 years

First QC Date

December 23, 2021

Last Update Submit

July 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosed as a difficult airway

    Cormack-Lehane was used for grading the best glottic view. In grade the entire glottis was visible; in grade 2 a portion of the glottis was visible; in grade 3 only the epiglottis could be seen; and in grade 4 the epiglottis was not visible. A score of 3-4 indicated difficult video laryngoscopy

    0-10minutes after intubation

Study Arms (2)

difficult airway

C-L≥3 grade

Diagnostic Test: Ultrasonic test

none difficult airway

C-L\<3 grade

Diagnostic Test: Ultrasonic test

Interventions

Ultrasonic testDIAGNOSTIC_TEST

Ultrasonic test to the patient's head, neck and jaw area.

difficult airwaynone difficult airway

Eligibility Criteria

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

adults who intend to undergo tracheal intubation under general anesthesia

You may qualify if:

  • ASA classification is 1-3
  • Patients who intend to undergo tracheal intubation under general anesthesia
  • Age ≥ 18 years old

You may not qualify if:

  • Patients with speech communication and cooperation barriers;
  • Patients with open head and neck trauma
  • Patients with cervical spine fractures or cervical spine diseases;
  • Emergency surgery;
  • Patients who are allergic to related drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 9Th Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 26, 2022

Study Start

December 18, 2021

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

July 13, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations