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Completed

NCT Number: NCT04472195

Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anesthesia Residents
  • SRNA
  • Pediatric Anesthesia Fellows

Exclusion criteria

  • Medical Students
  • Off-Service Rotators

Treatment and study plan

Simulation Airway Coaching

Other

Airway coaching on laryngoscopy technique for intubation of neonates/infants within 1 hour of case utilizing RCDP simulation technique.

Primary outcomes

  1. 1st attempt success rate

    Time frame: Through study completion, anticipated 12-15 months

    Trainee first attempt success rate will be observed by the study team

Secondary outcomes

  1. Complication rate

    Time frame: Through study completion, anticipated 12-15 months

    Trainee complication rates of laryngoscopy will be observed by the study team

  2. Self evaluation of neonate/infant laryngoscopy

    Time frame: Through study completion, anticipated 12-15 months

    Trainees will fill out Likert questions developed in conjunction with Boston Children's Survey Methodologist

  3. Evaluation of utility of JIT/RCDP

    Time frame: Through study completion, anticipated 12-15 months

    Trainees will fill out Likert Questions developed in conjunction with Boston Children's Survey Methodologist

  4. Cognitive Load in intubating patient

    Time frame: Through study completion, anticipated 12-15 months

    NASA-TLX will be administered to trainees to evaluate cognitive task load

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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