Impact of Stress on Performance of Neonatal Endotracheal Intubation
Impact of Stress on Performance of Neonatal Endotracheal Intubation
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.
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.
Inclusion Criteria:

 -  All residents enrolled in the pediatric residency program and subspecialties of
 University of Montreal.

 Exclusion Criteria:

 -  Residents who have a medical condition that can impact cortisol levels, such as
 pregnancy, will be excluded from the cortisol analysis.