Clinical trial NCT04472195: Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study
Official title: Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 182
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-crossover, Prospective Randomized Controlled Trial
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the impact of Just-In-Time (J-I-T) Rapid Cycle Deliberate Practice (RCDP) Simulation Training on laryngoscopy competency among novice pediatric anesthesia trainees.

Detailed description: Multiple intubation attempts in infants are potentially more harmful than previously suspected. Emerging literature suggests each additional attempt past an initial laryngoscopy correlates with a two-fold increase in complications. Therefore, striving to secure the neonate/infant airway on the first attempt is optimal for infant safety. Novice trainees lack experience with airway management in small children. To promote a patient safety culture among the multitude of rotating trainees at Boston Children's Hospital the investigators would like to augment airway management with Rapid Cycle Deliberate Practice Simulation Training (RCDP). Rotating trainees at BCH main campus will be prospectively randomized to experimental vs. control group for intubation of neonates and infants less than or equal to 12 months of age. Infants with known congenital heart disease, known or suspected difficult airways, or COVID-19 positive status will be excluded from the study. The experimental group will review a pre-induction airway management plan for their upcoming case and rapid cycle deliberate practice (RCDP) on a simulator with an anesthesia attending coaching on technique prior to real patient intubation. Primary outcome measure will be first attempt success rate. Other outcome measures include: complication rates, a team developed Likert scale that investigates intubation competency and utility of JIT/RCDP training, and NASA-TLX (a validated cognitive task load index).

The study would be the first to directly determine how and if simulation-based pediatric airway interventions are immediately transferable to actual clinical environments in pediatric anesthesiology. Such a study may change how training programs prepare novices for "game time" performance and become a new standard of care in airway management training.

Eligibility criteria: Inclusion Criteria:

* Anesthesia Residents
* SRNA
* Pediatric Anesthesia Fellows

Exclusion Criteria:

* Medical Students
* Off-Service Rotators

Primary outcomes:
measure: 1st attempt success rate
timeFrame: Through study completion, anticipated 12-15 months
Secondary outcomes:
measure: Complication rate
timeFrame: Through study completion, anticipated 12-15 months
measure: Self evaluation of neonate/infant laryngoscopy
timeFrame: Through study completion, anticipated 12-15 months
measure: Evaluation of utility of JIT/RCDP
timeFrame: Through study completion, anticipated 12-15 months
measure: Cognitive Load in intubating patient
timeFrame: Through study completion, anticipated 12-15 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hopsital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Stephen Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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