The DAnish VIdeo IntubaTION (DA-VITION) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLise Aunsholt
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Video-directed endotracheal intubation
Procedure/SurgeryThere 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.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Patients undergoing endotracheal intubation1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The landmarks will be identified on the multimedia file from the procedure.2
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.
Time frame
The landmarks will be identified on the multimedia file from the procedure.3
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.
Time frame
The landmarks will be identified on the multimedia file from the procedure.4
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.
Time frame
The landmarks will be identified on the multimedia file from the procedure.Secondary outcomes
1
Time consumption of the course.
A course is defined as one method for intubation (i.e., the same airway device, approach, and medication regimen). Many attempts by multiple providers are allowed within a given course as long as all attempts are made using the same method.
Time frame
During the procedure.2
Number of attempts.
The number of attempts (one, two, and three or more).
Time frame
During the procedure.3
Successful endotracheal intubation.
Successful endotracheal intubation is defined as correct endotracheal tube placement in the trachea confirmed by chest rise, auscultation, waveform monitor for end-tidal CO2, and/or chest radiograph in first, second, or three attempts.10,19 First-attempt success is defined according to previous studies as successful intubation on the first attempt by the first provider. Success within two attempts is defined as successful intubation on the second attempt by the same provider. Success within 3 attempts is defined as successful intubation on any attempt by the same provider.
Time frame
During the procedure.4
Overall course success.
Overall course success is defined as successful intubation by any provider on any attempt within that course.
Time frame
During the procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lise Aunsholt
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Copenhagen Academy for Medical Education and Simulation
Collaborator
Source ClinicalTrials.gov