NCT05884645

Brief Summary

This study aims to train an AI for video-directed endotracheal intubation (VITION) to recognise the anatomical structures of the upper airway during video-directed endotracheal intubations.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

May 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

May 23, 2023

Last Update Submit

September 17, 2024

Conditions

Intubation ComplicationIntubation; Difficult or Failed

Keywords

video-guided endotracheal intubationartificial intelligencevideolaryngoscope

Outcome Measures

Primary Outcomes (4)

  • Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    The landmarks will be identified on the multimedia file from the procedure.

  • Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    The landmarks will be identified on the multimedia file from the procedure.

  • Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    The landmarks will be identified on the multimedia file from the procedure.

  • AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway.

    The landmarks will be identified on the multimedia file from the procedure.

Secondary Outcomes (7)

  • Time consumption of the course.

    During the procedure.

  • Number of attempts.

    During the procedure.

  • Successful endotracheal intubation.

    During the procedure.

  • Overall course success.

    During the procedure.

  • Severe oxygen desaturations

    During the procedure.

  • +2 more secondary outcomes

Study Arms (1)

Patients undergoing endotracheal intubation

Patients across all ages undergoing endotracheal intubation.

Procedure: Video-directed endotracheal intubation

Interventions

Video-directed endotracheal intubationPROCEDURE

There will be no intervention in this prospective observational cohort study. Endotracheal intubation is already used to secure the airway by placing an endotracheal tube into the trachea via the oral or nasal route. Indications include the need for airway control during general anaesthesia, mechanical ventilation, resuscitation, and various forms of acute respiratory distress.

Patients undergoing endotracheal intubation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will include patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation in the Capital Region of Denmark.

You may qualify if:

  • ● Undergoing video-directed oral or nasal endotracheal intubation.

You may not qualify if:

  • Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis).
  • Failed attempt by video laryngoscopy due to malfunctioning equipment.
  • Missing or corrupted video recording.
  • Informed consent is not obtained from the participants or participants' parents / legal guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

ACTIVE NOT RECRUITING

Capital Region of Denmark

Copenhagen, Denmark

RECRUITING

Study Officials

  • Niklas Breindahl, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niklas Breindahl, MD

CONTACT

+4528566410niklas.breindahl@gmail.com

Lise Aunsholt, MD, PhD

CONTACT

61991137lise.aunsholt@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 1, 2023

Study Start

May 1, 2023

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The Capital Region in Denmark retains all rights to the collected data, which must not be shared without approval.

Locations

DK(2)