Just-in-time Training for Teaching Neonatal Endotracheal Intubation

Simulation-based Just-in-time Training for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Education; Simulation Training
• Intervention / Treatment: Other: Simulation-based just-in-time training; Other: Video training

Detailed Description

The study will be a prospective randomized controlled trial, taking place in the NICU of CHU Sainte-Justine in Montréal, Quebec, Canada ; Montreal Children's Hospital of the MUHC, in Montreal, Quebec, Canada; CHU de Quebec-Universite Laval, CHU de Sherbrooke and the General Jewish Hospital.

Simulation-based just-in-time training

Simulation-based just-in-time training, completed before performing endotracheal intubation, will consist of 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). The videos of the neonatal glottises have been locally created, after parent consent, using live recordings of endotracheal intubations performed with the C-MAC videolarygnoscope (Karl Storz GmbH & Co. KG, Tuttlingen, Germany). The low fidelity simulation will be performed in situ in the physician meeting room in the neonatal intensive care unit. Senior providers will be instructed to also educate the resident to different aspects related to the procedure: indications, contraindications, anatomy, equipment, personnel, potential complications, appropriate aftercare and common pitfalls.

Video training

Residents will watch a 5 minutes video regarding endotracheal intubation, which covers the following topics: indications, contraindications, anatomy, equipment, personnel, procedural steps, potential complications, appropriate aftercare and common pitfalls.

Definitions

1. Intubation is a success if the endotracheal tube is placed in the trachea under the vocal cords. It is defined according to usual clinical norms: change in color of the carbon dioxide detector, vapour in the endotracheal tube, thoracic expansion, assessment of bilateral lung air entry, absence of air entry in the stomach by auscultation, and improvement of patient's clinical parameters: heart rate and arterial oxygen saturation.
2. Time to intubation is defined as the time from insertion of the laryngoscope blade in the patients' mouth until it is pulled out.
3. Oesophageal intubation is diagnosed when there is absence of clinical signs of a successful endotracheal intubation and possibly air entry in the stomach by auscultation.
4. Right bronchial main stem intubation is diagnosed on chest x-ray.
5. A trial is counted as an attempt if there has been insertion of the laryngoscope blade in the patient's mouth.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Laval, Quebec, Canada, G1V 4G2
      • Centre Hospitalier de l'Universite Laval
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine
    • Montréal, Quebec, Canada, H3G 1A4
      • The Montreal Children's Hospital MUHC
    • Montréal, Quebec, Canada, H3T 1E2
      • General Jewish Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Université de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Trainees: No exclusion criteria.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Simulation-based just-in-time training; 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 and low fidelity simulation (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada)
ACTIVE_COMPARATOR: Video training; 5 minutes video regarding endotracheal intubation	Other: Video training; Video describing endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endotracheal intubation success rate	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successful intubation	Defined as the time from insertion of the laryngoscope blade in the patients' mouth until it is pulled out.	5 minutes
Endotracheal intubation related complications	mucosal trauma, oesophageal intubation and endobronchial intubation	15 minutes
Resident's level of confidence	survey	15 minutes

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: CHU de Quebec-Universite Laval; Université de Sherbrooke; Jewish General Hospital; Montreal Children's Hospital of the MUHC

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (ESTIMATE): June 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: endotracheal intubation; teaching; just-in-time
• Other Study ID Numbers: 5443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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