Artificial Intelligence in Paediatric Video IntubaTION (VITION-AI)

Study Overview
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Brief Summary
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This study aims to train an AI for video-directed endotracheal intubation (VITION-AI) to recognise the anatomical structures in children under five years during video-directed endotracheal intubations.

Detailed Description
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Study design The VITION-AI study protocol describes the design of a prospective, observational pilot study. Inclusion will commence in 2023 at Copenhagen University Hospital, Rigshospitalet. Participants We will include patients less than five years in the following age groups according to the anticipated differences in upper airway anatomy: 1) <36 weeks of gestational age (GA), 2) from 36 weeks GA to less than one month, 3) from 1 month to less than one year, 4) from one year to less than two years, and 5) from two years to five years. Inclusion criteria Patients are eligible if they adhere to all the following inclusion criteria: Less than five years and 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 video recording. Informed consent is not obtained from the participants or participants' parents / legal guardians. Interventions and comparisons This prospective, observational pilot study will have no interventions or comparisons. Primary objective The primary objective is to characterize anatomical landmarks and performances of paediatric intubations in a large and diverse pool of clinicians and children under five years.

Official Title
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Artificial Intelligence in Paediatric Video IntubaTION (VITION-AI): A Prospective Observational Pilot Study

Conditions
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Pediatric ALL, Intubation Complication, Intubation; Difficult or Failed

Intervention / Treatment
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* Procedure: Video-directed endotracheal intubation


Participation Criteria
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Eligibility Criteria
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Patients are eligible if they adhere to all the following inclusion criteria: Less than five years and 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.

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| <36 weeks of gestational age.<br>50 participants in each cohort according to the anticipated differences in upper airway anatomy. | Procedure: Video-directed endotracheal intubation<br>* 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.<br>|
| From 36 weeks GA to less than one month.<br>50 participants in each cohort according to the anticipated differences in upper airway anatomy. | Procedure: Video-directed endotracheal intubation<br>* 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.<br>|
| From 1 month to less than one year.<br>50 participants in each cohort according to the anticipated differences in upper airway anatomy. | Procedure: Video-directed endotracheal intubation<br>* 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.<br>|
| From one year to less than two years.<br>50 participants in each cohort according to the anticipated differences in upper airway anatomy. | Procedure: Video-directed endotracheal intubation<br>* 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.<br>|
| From two years to five years.<br>50 participants in each cohort according to the anticipated differences in upper airway anatomy. | Procedure: Video-directed endotracheal intubation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical landmarks. | The primary objective is to characterize anatomical landmarks in the upper airway in a large and diverse pool of clinicians and children under five years. | 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. | 
| Number of attempts. | The number of attempts (one, two, and three or more). Studies, including the National Emergency Airway Registry for Children (NEAR4KIDS)20 have reported an increased risk of tracheal intubation-associated events with the number of intubations in adults and children.21-29 The procedure is restricted in terms of time, from introducing the laryngoscope blade into the oral cavity to removing the laryngoscope.10,19 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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video-guided endotracheal intubation, pediatric, artificial intelligence