Orotracheal Intubation Clinical Trial
Official title:
Effectiveness of "Just-In-Time" Training With/Without a High Fidelity Simulation on Patient Safety in Airway Management in Pediatric Intensive Care Unit
This is a prospective interventional study to test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
Background:
Appropriate airway management is the most critical point in pediatric resuscitation and
pediatric critical care. It remains, however, a challenge for pediatric residents to learn
and retain this critical skill. Recent report from our PICU showed pediatric residents
participated only 28% of initial orotracheal intubation, and the rate of the first
successful endotracheal tube placement was only 38% of all orotracheal intubation attempt.
Repetitive poor-skilled intubation attempts may be associated with complication such as
dental or laryngeal contusion, and prolonged intubation attempt may be associated with
hypoxia and hemodynamic instability. In order to improve the operational performance in the
efficacy (first attempt success rate) and safety (minimizing the associated events which
could potentially lead to adverse events), a better training method is warranted.
Objectives:
To test the hypothesis that just-in-time training for pediatric airway management may
improve patient safety and operational performance of orotracheal intubation and decreases
intubation associated events in pediatric residents in the PICU. To test the hypothesis that
high fidelity simulation may enhance the training efficacy and patient safety in simulation
settings.
Study Design:
This is a prospective interventional study. During the eighteen months of study period, one
of two on-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of
just-in-time pediatric airway management training. This training will occur before their
shift starts before the morning round. This training will cover direct laryngoscopy
technique, orotracheal intubation technique, confirmation of the tube placement and
recognition of associated events. This training will be done with or without high fidelity
simulation function. We will use SimBaby (Laerdal, Norway). The assignment will be
randomized. The clinical data of orotracheal intubation are collected through NEAR-4 KIDS
registry. Primary outcome is a change in a first attempt success rate by the residents in an
overtrained group (7 South PICU) compared to standard training group (7 East PICU). The
secondary outcome is the rate of resident participation in orotracheal intubation attempt,
the number of intubation attempt before successful intubation by residents and the number of
intubation associated events. The videotaped performance during the training is analyzed
with Healthcare Failure Mode and Effect Analysis (HFMEA) and will be compared between high
fidelity simulation training group and low fidelity simulation training group. The
evaluation system developed by HFMEA will be validated by a performance of experienced and
non-experienced intubators. Furthermore, the real orotracheal intubation team performance in
both PICUs will be evaluated with scale by a research assistant. The demographic and
training data of participants of real PICU intubations will be collected. No patient
identifiable information will be collected. This data will also be kept in a
password-protected research computer.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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