Video Intelligence intubaTION (VITION)

Intubation Complication Clinical Trial

— VITION  

Official title:

Video Intelligence intubaTION (VITION): A Prospective Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05884645
• Other study ID #: VITION
• Status: Active, not recruiting
• Start date: May 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed

Intervention

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.

Locations

Country	Name	City	State
Denmark	Capital Region of Denmark	København
Denmark	Rigshospitalet	København

Sponsors (2)

Lead Sponsor	Collaborator
Lise Aunsholt	Copenhagen Academy for Medical Education and Simulation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	Number of attempts.	The number of attempts (one, two, and three or more).	During the procedure.
Secondary	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.
Secondary	Overall course success.	Overall course success is defined as successful intubation by any provider on any attempt within that course.	During the procedure.
Secondary	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.
Secondary	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
Secondary	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