Video Intelligence intubaTION (VITION) (VITION)

Video Intelligence intubaTION (VITION): A Prospective Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intubation Complication; Intubation; Difficult or Failed
• Intervention / Treatment: Procedure: Video-directed endotracheal intubation

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• Denmark
  • København, Denmark, 2100
    • Rigshospitalet
  • København, Denmark
    • Capital Region of Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing endotracheal intubation; Patients across all ages undergoing endotracheal intubation.

Procedure: Video-directed endotracheal intubation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure.
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.	During the procedure.
Overall course success.	Overall course success is defined as successful intubation by any provider on any attempt within that course.	During the procedure.
Severe oxygen desaturations	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.	During the procedure.
Non-severe TIAEs	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.	72 hours after the procedure
Severe TIAEs	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).	72 hours after the procedure
Number of attempts.	The number of attempts (one, two, and three or more).	During the procedure.

Collaborators and Investigators

• Sponsor: Lise Aunsholt
• Collaborators: Copenhagen Academy for Medical Education and Simulation
• Investigators: Principal Investigator: Niklas Breindahl, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: artificial intelligence; videolaryngoscope; video-guided endotracheal intubation
• Other Study ID Numbers: VITION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Capital Region in Denmark retains all rights to the collected data, which must not be shared without approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No