Clinical trial NCT02809924: Just-in-time Training for Teaching Neonatal Endotracheal Intubation
Official title: Simulation-based Just-in-time Training for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Education
Simulation Training
Keywords: endotracheal intubation
teaching
just-in-time
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Montreal Children's Hospital of the MUHC
name: CHU de Quebec-Universite Laval
name: Université de Sherbrooke
name: Jewish General Hospital
First posted: 2016-06-22
Enrollment: 180
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Endotracheal intubation success rate
timeFrame: 5 minutes
Secondary outcomes:
measure: Time to successful intubation
timeFrame: 5 minutes
measure: Endotracheal intubation related complications
timeFrame: 15 minutes
measure: Resident's level of confidence
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Centre Hospitalier de l'Université Laval
state: Quebec
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: The Montreal Children's Hospital MUHC
state: Quebec
city: Montréal
country: Canada
facility: General Jewish Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Ahmed Moussa, MD
role: PRINCIPAL_INVESTIGATOR
References: