NCT07508826

Brief Summary

This study evaluates artificial intelligence (AI)-assisted videolaryngoscopy for endotracheal intubation in a simulated pediatric airway environment. Healthcare providers with varying levels of airway management experience will perform intubations on pediatric and neonatal mannequins using either AI-assisted videolaryngoscopy (larynGuide) or conventional videolaryngoscopy. Participants will be randomized to perform intubation tasks using one of the two techniques. The primary outcome is the time required for successful intubation. Secondary outcomes include first-attempt success rate, number of attempts, airway visualization (POGO score), usability of the AI system measured by the System Usability Scale (SUS), and gaze tracking metrics evaluating user interaction with visual guidance. This equivalence randomized controlled trial aims to determine whether AI-assisted videolaryngoscopy performs comparably to conventional videolaryngoscopy while potentially improving success rates and user experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

March 25, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

intubationmannikinsimulationartificial intelligencelarynguideneonatesinfantschildren

Outcome Measures

Primary Outcomes (1)

  • Time required for intubation

    baseline, pre-intervention/procedure/surgery

Secondary Outcomes (2)

  • First-attempt success rate

    baseline, pre-intervention/procedure/surgery

  • POGO score

    baseline, pre-intervention/procedure/surgery

Other Outcomes (6)

  • SUS score

    baseline, pre-intervention/procedure/surgery

  • Translated POGO score

    baseline, pre-intervention/procedure/surgery

  • Intubation status (good vs bad vs not started)

    baseline, pre-intervention/procedure/surgery

  • +3 more other outcomes

Study Arms (2)

AI-assisted videolaryngoscopy

EXPERIMENTAL

Participants perform simulated endotracheal intubation using videolaryngoscopy integrated with the AI guidance system

Other: AI-assisted videolaryngoscopy

Conventional videolaryngoscopy

ACTIVE COMPARATOR

Participants perform simulated endotracheal intubation using standard videolaryngoscopy without AI assistance.

Other: Conventional Intubation

Interventions

Participants perform simulated endotracheal intubation using videolaryngoscopy integrated with the AI guidance system

AI-assisted videolaryngoscopy

Traditional intubation

Conventional videolaryngoscopy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any healthcare worker or trainee

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Canada

Location

Related Publications (2)

  • Nemani S, Goyal S, Sharma A, Kothari N. Artificial intelligence in pediatric airway - A scoping review. Saudi J Anaesth. 2024 Jul-Sep;18(3):410-416. doi: 10.4103/sja.sja_110_24. Epub 2024 Jun 4.

    PMID: 39149736BACKGROUND
  • Matava C, Pankiv E, Ahumada L, Weingarten B, Simpao A. Artificial intelligence, machine learning and the pediatric airway. Paediatr Anaesth. 2020 Mar;30(3):264-268. doi: 10.1111/pan.13792. Epub 2020 Jan 2.

    PMID: 31845543BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will be randomized to perform simulated endotracheal intubation using either AI-assisted videolaryngoscopy or conventional videolaryngoscopy. Each participant will perform intubation on both child and neonatal mannequins
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 2, 2026

Study Start

May 1, 2026

Primary Completion

June 30, 2026

Study Completion

July 20, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations