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Completed

NCT Number: NCT02809924

Just-in-time Training for Teaching Neonatal Endotracheal Intubation

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.

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Key information

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université Laval, Laval, Quebec, Canada

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About this study

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

  • 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.
  • Time to intubation is defined as the time from insertion of the laryngoscope blade in the patients' mouth until it is pulled out.
  • 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.
  • Right bronchial main stem intubation is diagnosed on chest x-ray.
  • A trial is counted as an attempt if there has been insertion of the laryngoscope blade in the patient's mouth.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Simulation-based just-in-time training

Other

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

video training

Other

Video describing endotracheal intubation

Primary outcomes

  1. Endotracheal intubation success rate

    Time frame: 5 minutes

Secondary outcomes

  1. Time to successful intubation

    Time frame: 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

    Time frame: 15 minutes

    mucosal trauma, oesophageal intubation and endobronchial intubation

  3. Resident's level of confidence

    Time frame: 15 minutes

    survey

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

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

Registry information

Official study title

Simulation-based Just-in-time Training for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2016
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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