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.
