Just-in-time Training for Teaching Neonatal Endotracheal Intubation

Sponsor
St. Justine's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02809924
Collaborator
Montreal Children's Hospital of the MUHC (Other), CHU de Quebec-Universite Laval (Other), Université de Sherbrooke (Other), Jewish General Hospital (Other)
180
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulation-based just-in-time training
  • Other: Video training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Simulation-based Just-in-time Training for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Endotracheal intubation success rate [5 minutes]

Secondary Outcome Measures

  1. Time to successful intubation [5 minutes]

    Defined as the time from insertion of the laryngoscope blade in the patients' mouth until it is pulled out.

  2. Endotracheal intubation related complications [15 minutes]

    mucosal trauma, oesophageal intubation and endobronchial intubation

  3. Resident's level of confidence [15 minutes]

    survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Year
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de l'Université Laval Laval Quebec Canada G1V 4G2
2 CHU Sainte-Justine Montreal Quebec Canada H3T 1C5
3 The Montreal Children's Hospital MUHC Montréal Quebec Canada H3G 1A4
4 General Jewish Hospital Montréal Quebec Canada H3T 1E2
5 Université de Sherbrooke Sherbrooke Quebec Canada J1H 5N4

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Ahmed Moussa, MD, St. Justine's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Moussa, Neonatologist, Clinical assistant professor, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT02809924
Other Study ID Numbers:
  • 5443
First Posted:
Jun 22, 2016
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Moussa, Neonatologist, Clinical assistant professor, St. Justine's Hospital

Study Results

No Results Posted as of Oct 7, 2021