Video Intelligence intubaTION (VITION)

Active, not recruiting

• Conditions: Intubation Complication; Intubation; Difficult or Failed
• Interventions: Procedure: Video-directed endotracheal intubation

• Registration Number: NCT05884645
• Lead Sponsor: Lise Aunsholt

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing endotracheal intubation	Video-directed endotracheal intubation	Patients across all ages undergoing endotracheal intubation.

Primary Outcome Measures

Name	Time	Method
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.	Accuracy 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.	Sensitivity 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.	Specificity 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.	AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway.

Secondary Outcome Measures

Name	Time	Method
Number of attempts.	During the procedure.	The number of attempts (one, two, and three or more).
Time consumption of the course.	During the procedure.	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.
Overall course success.	During the procedure.	Overall course success is defined as successful intubation by any provider on any attempt within that course.
Non-severe TIAEs	72 hours after the procedure	Non-severe TIAEs: Oesophageal intubation with immediate recognition, dysrhythmia including any duration of heart rate \<60 beats per minute without chest compressions, main-stem bronchial intubation, emesis without aspiration, pain or agitation requiring additional medications causing a delay in intubation, epistaxis, lip trauma, dental injury, medication error, and hypertension.
Severe oxygen desaturations	During the procedure.	Severe oxygen desaturations are defined according to previous studies as a 20% or more decrease in oxygen saturation from the highest level immediately before the first attempt.
Severe TIAEs	72 hours after the procedure	Severe TIAEs: Cardiac arrest requiring chest compressions, oesophageal intubation with delayed recognition (defined as placement of the endotracheal tube into the oesophagus or hypopharynx with clinical deterioration, e.g., desaturation, before removal of the misplaced tube), emesis with aspiration, hypotension requiring therapy, laryngospasm, pneumothorax or pneumo-mediastinum, and direct airway injury (e.g., vocal cord injury, laryngeal injury, tracheal injury, false passage creation).
Successful endotracheal intubation.	During the procedure.	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.

Trial Locations

Locations (2)

Rigshospitalet; 🇩🇰 København, Denmark

Capital Region of Denmark; 🇩🇰 København, Denmark