NCT02809924

Brief Summary

This study compares the use of simulation-based just-in-time training to video training in learning neonatal endotracheal intubation. Half of the participants will be trained using simulation-based just-in-time training and the other half using video training. The hypothesis are Primary hypothesis: In the Neonatal Intensive Care Unit, use of simulation-based just-in-time training, compared to video training, will increase the rate of successful clinical endotracheal intubation by 20%. Secondary hypotheses: The investigators expect that simulation-based just-in-time training prior to clinical endotracheal intubation will decrease time to successful intubation and rate of endotracheal intubation related adverse events, namely mucosal trauma, oesophageal and endobronchial intubations. In addition, the investigators expect that simulation-based just-in-time training will increase residents' confidence level while performing clinical endotracheal intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

4.3 years

First QC Date

June 20, 2016

Last Update Submit

October 5, 2021

Conditions

IntubationEducationSimulation Training

Keywords

endotracheal intubationteachingjust-in-time

Outcome Measures

Primary Outcomes (1)

  • Endotracheal intubation success rate

    5 minutes

Secondary Outcomes (3)

  • Time to successful intubation

    5 minutes

  • Endotracheal intubation related complications

    15 minutes

  • Resident's level of confidence

    15 minutes

Study Arms (2)

Simulation-based just-in-time training

EXPERIMENTAL

Viewing a short video showing the neonatal glottis of similar gestational age to the patient that is being intubated followed by practice on a mannequin (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada) with supervision and feedback from a senior provider (low fidelity simulation).

Other: Simulation-based just-in-time training

Video training

ACTIVE COMPARATOR

5 minutes video regarding endotracheal intubation

Other: Video training

Interventions

Simulation-based just-in-time trainingOTHER

Video and low fidelity simulation (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada)

Simulation-based just-in-time training
Video trainingOTHER

Video describing endotracheal intubation

Video training

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All residents registered in the three first years of the general paediatrics program at University of Montreal, McGill University, University of Sherbrooke and University Laval will be approached to participate in the study.
  • All endotracheal intubation procedures attempted by paediatric residents in the neonatal intensive care unit at CHU Sainte-Justine; at Montreal Children's Hospital of the MUHC; at CHU de Quebec-Universite Laval , at CHU de Sherbrooke and at General Jewish Hospital (McGill university) will be included in the study, regardless of the patient weight or gestational age.

You may not qualify if:

  • Patients with major oral, cervical or upper airway malformations, urgent endotracheal intubations with the inability to prepare the Just-in-time training material, and an unexpected difficult endotracheal intubation (needing the assistance of the anaesthetist).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier de l'Université Laval

Laval, Quebec, G1V 4G2, Canada

Location

The Montreal Children's Hospital MUHC

Montreal, Quebec, H3G 1A4, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

General Jewish Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • Gizicki E, Assaad MA, Masse E, Belanger S, Olivier F, Moussa A. Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21.

    PMID: 37353151DERIVED

Study Officials

  • Ahmed Moussa, MD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist, Clinical assistant professor

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

July 1, 2017

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

October 7, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(5)