IntubationNCT02809924
Just-in-time Training for Teaching Neonatal Endotracheal Intubation
A study testing Simulation-based just-in-time training and Video training in people with Intubation and Education, run by St. Justine's Hospital at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Intubation, Education, Simulation Training
- What is being tested?
- Simulation-based just-in-time training and Video training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Jul 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Centre Hospitalier de l'Université Laval
Laval, Quebec, G1V 4G2
The Montreal Children's Hospital MUHC
Montreal, Quebec, H3G 1A4
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
General Jewish Hospital
Montreal, Quebec, H3T 1E2
Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Simulation-based Just-in-time Training for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial
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
Read more
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.
Read the 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
- 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.
- Conditions
- Intubation, Education, Simulation Training
- Being tested
- Simulation-based just-in-time training, Video training
- Keywords
- endotracheal intubation, teaching, just-in-time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based just-in-time trainingOther
Video and low fidelity simulation (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada)
Video trainingOther
Video describing endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Simulation-based just-in-time training | Experimental | 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). Receives: Other: Simulation-based just-in-time training |
| Video training | Active comparator | 5 minutes video regarding endotracheal intubation Receives: Other: Video training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation success rate
Measured: 5 minutes
Secondary outcomes (3)
Time to successful intubation
Defined as the time from insertion of the laryngoscope blade in the patients' mouth until it is pulled out.
Measured: 5 minutes
Endotracheal intubation related complications
mucosal trauma, oesophageal intubation and endobronchial intubation
Measured: 15 minutes
Resident's level of confidence
survey
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 Jul 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Children's Hospital of the MUHC, CHU de Quebec-Universite Laval, Université de Sherbrooke, Jewish General Hospital
- Responsible party
- Principal investigator, Ahmed Moussa, St. Justine's Hospital
- Investigators
- Ahmed Moussa, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809924
- Sponsor's protocol ID
- 5443
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2016
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gizicki E, Assaad MA, Masse E, Belanger S, Olivier F, Moussa A. Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21.
PubMed 37353151
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Just-in-time Training for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02809924
- Acronym / sponsor ID
- 5443
- Conditions
- Intubation, Education, Simulation Training
- Keywords
- endotracheal intubation, teaching, just-in-time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Montreal Children's Hospital of the MUHC, CHU de Quebec-Universite Laval, Université de Sherbrooke, Jewish General Hospital
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation-based just-in-time training | Experimental | Other: Simulation-based just-in-time trainingViewing 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). |
| Video training | Active comparator | Other: Video training5 minutes video regarding endotracheal intubation |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based just-in-time trainingVideo and low fidelity simulation (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada) | Other | Simulation-based just-in-time training |
| Video trainingVideo describing endotracheal intubation | Other | Video training |
Primary outcome
Endotracheal intubation success rate
Time frame: 5 minutes
3 secondary outcomes
Time to successful intubation
Time frame: 5 minutes
Endotracheal intubation related complications
Time frame: 15 minutes
Resident's level of confidence
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Derived from this study: PubMed 37353151Gizicki E, Assaad MA, Masse E, Belanger S, Olivier F, Moussa A. Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Moussa, MD principal investigator
St. Justine's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based just-in-time training and Video training in people with Intubation and Education, run by St. Justine's Hospital at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal intubation success rate (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.