Clinical trial NCT02758704: Impact of Stress on Performance of Neonatal Endotracheal Intubation
Official title: Impact of Stress on the Performance of Neonatal Endotracheal Intubation: A Randomized Controlled Trial on Manikins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Intubation Performance
Keywords: Intubation
Neonatal
Teaching
Stress
Simulation
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
First posted: 2016-05-02
Enrollment: 58
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of endotracheal intubation procedure
timeFrame: 5 minutes
measure: Intubation skill performance
timeFrame: within 24 months
Secondary outcomes:
measure: Rate of esophageal intubation
timeFrame: 5 minutes
measure: Stress level - Cortisol Measurement
timeFrame: within 24 months
measure: Stress level - Heart Rate
timeFrame: within 24 months
measure: Stress level - STAI Questionnaire
timeFrame: within 24 months
measure: Duration of intubation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Montreal
country: Canada
facility: Sainte-Justine Hospital
state: Quebec
Study officials:
References: