Clinical trial NCT05884645: The DAnish VIdeo IntubaTION (DA-VITION) Study
Official title: The DAnish VIdeo IntubaTION (DA-VITION) Study: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intubation Complication
Intubation; Difficult or Failed
Keywords: video-guided endotracheal intubation
artificial intelligence
videolaryngoscope
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Academy for Medical Education and Simulation
First posted: 2023-06-01
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Detailed description: Study design

The VITION study protocol describes the design of a prospective, observational study. Inclusion will commence in 2023 at the anesthesia and intensive care departments in the Capital Region of Denmark.

Participants

Patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

* Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis17,18).
* 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.

Interventions and comparisons

This prospective, observational study will have no interventions or comparisons.

Primary objective

The primary objective is to characterize anatomical landmarks and performances of intubations in a large and diverse pool of clinicians and patients.

Eligibility criteria: Patients are eligible if they adhere to all the following inclusion criteria:

● Undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

* 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.

Primary outcomes:
measure: Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway.
timeFrame: The landmarks will be identified on the multimedia file from the procedure.
measure: Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway.
timeFrame: The landmarks will be identified on the multimedia file from the procedure.
measure: Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway.
timeFrame: The landmarks will be identified on the multimedia file from the procedure.
measure: AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway.
timeFrame: The landmarks will be identified on the multimedia file from the procedure.
Secondary outcomes:
measure: Time consumption of the course.
timeFrame: During the procedure.
measure: Number of attempts.
timeFrame: During the procedure.
measure: Successful endotracheal intubation.
timeFrame: During the procedure.
measure: Overall course success.
timeFrame: During the procedure.
measure: Severe oxygen desaturations
timeFrame: During the procedure.
measure: Non-severe TIAEs
timeFrame: 72 hours after the procedure
measure: Severe TIAEs
timeFrame: 72 hours after the procedure
Other outcomes:
Locations:
city: København
country: Denmark
facility: Rigshospitalet
city: København
country: Denmark
facility: Capital Region of Denmark
Study officials:
affiliation: Rigshospitalet, Denmark
name: Niklas Breindahl, MD
role: PRINCIPAL_INVESTIGATOR
References: