Just-in-time Training for Teaching Neonatal Endotracheal Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

"Just-In-Time Training" in Pediatric Airway Management

NCT00631176

Orotracheal Intubation

COMPLETED NA

Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation

NCT02163382

Respiratory Failure

COMPLETED NA

Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study

NCT04472195

Anesthesia

COMPLETED NA

Chest Pressure for Intubated Peds Patients

NCT02615834

Noninvasive Ventilation

WITHDRAWN NA

Pilot Study for Sedation Interruption in Children

NCT02426320

Daily Sedative Interruption Sedation Strategies Sedation Protocols +2 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation Education Simulation Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Simulation-based just-in-time training

Intervention Type OTHER

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

Video training

5 minutes video regarding endotracheal intubation

Group Type ACTIVE_COMPARATOR

Video training

Intervention Type OTHER

Video describing endotracheal intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simulation-based just-in-time training

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

Intervention Type OTHER

Video training

Video describing endotracheal intubation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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).

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No