Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02758704 |
| Other study ID # |
4143 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
June 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 will be a randomized controlled trial designed to analyse the impact of stress on
the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric
residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS)
environment where they will be asked to perform a standard neonatal intubation procedure.
Subjects will then cross-over to the second scenario within a short window (1-2 weeks).
Outcome measures include: endotracheal intubation success rate and assessment of the
procedure performance by video-review using a standardized checklist rated by two independent
reviewers. Stress level will be measured using salivary cortisol, heart rate and a
standardized anxiety questionnaire.
Description:
Although a required skill in pediatric residency programs, success rate of neonatal
endotracheal intubation (ETI) among trainees is known to be inadequate. Currently, it is
taught using simulation; a teaching method that seems useful mainly for limited short-term
retention of skill. In the clinical setting, ETI is often associated with stress, which could
explain the limited educational impact of simulation training. The effect of stress on the
success of this procedure is poorly studied.
Therefore, the objective of the investigators study is to assess the impact of stress on the
success of simulated neonatal ETI.
Hypotheses to be tested: The primary hypothesis is that stressful conditions will negatively
impact residents' success of endotracheal intubation on neonatal manikins. Secondary
hypotheses include: 1) stressful conditions will be associated with an increased time to
successful intubation and decreased performance on the intubation checklist; 2) there will be
a positive correlation between heart rate/cortisol levels and resident's response on the
State Trait Anxiety Inventory questionnaire (STAI).
Design: This study will be a crossover randomized controlled trial in the setting of the
simulation laboratory. Subjects will include pediatric residents and pediatric subspecialty
residents. Exclusion criteria will include any medical condition or medication that can have
a significant impact on cortisol levels. The residents will be randomized using sealed
envelopes to perform a neonatal ETI in a low or a high stress environment, and then crossover
to the other on a separate day. Stress will be created and standardized by using audio
alarms, third party supervisors and simulated manikin instability. Level of stress of
participants will be assessed at baseline during a lecture, upon arrival to the simulation
center and after the simulated procedure. This will be done using salivary cortisol, heart
rate and the STAI questionnaire. ETI procedures will be videotaped and performance will be
assessed by two external reviewers using a validated checklist.
Analysis: Primary and secondary outcomes include: success rate, checklist performance, time
to successful intubation, rate of esophageal intubation and stress levels (cortisol, heart
rate and questionnaire). Continuous variables will be analyzed by the independent sample t
test and categorical variables will be analyzed by Fisher's exact test. Statistical
significance will be defined by a 2-sided alpha of 0.05 and power of 80%. To demonstrate a
decrease of success rate of ETI from 80% (retrieved from previous simulation study in a LS
environment) to 60%, 64 intubations are needed per group.
Anticipated outcomes & potential problems: Demonstrating a decrease in success rate of ETI in
the HS environment will aid to improve simulation-based training of neonatal ETI. In the
future, the HS environment model can be used as an intermediate training process to prepare
residents to the stress related to this procedure in the clinical world.
