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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02809924
Other study ID # 5443
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Simulation-based just-in-time training
Video and low fidelity simulation (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada)
Video training
Video describing endotracheal intubation

Locations

Country Name City State
Canada Centre Hospitalier de l'Université Laval Laval Quebec
Canada CHU Sainte-Justine Montreal Quebec
Canada General Jewish Hospital Montréal Quebec
Canada The Montreal Children's Hospital MUHC Montréal Quebec
Canada Université de Sherbrooke Sherbrooke Quebec

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endotracheal intubation success rate 5 minutes
Secondary 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
Secondary Endotracheal intubation related complications mucosal trauma, oesophageal intubation and endobronchial intubation 15 minutes
Secondary Resident's level of confidence survey 15 minutes
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