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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04472195
Collaborator
(none)
182
1
2
37.9
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulation Airway Coaching
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Non-crossover, Prospective Randomized Controlled TrialNon-crossover, Prospective Randomized Controlled Trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

The experimental group will review a pre-induction airway management plan for their upcoming case and undergo a scripted 10-minute RCDP session with an airway coach within 1 hour of patient intubation. The intubation approach (DL vs. video assisted DL) will be chosen by the primary case attending and communicated to the airway coach to simulate the planned laryngoscopy attempt. The experimental group will then proceed with their scheduled case with a member of the research team observing the laryngoscopy attempt(s) to capture data.

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

No Intervention: Control

The trainees in the control group will have no interventions by the research team, only observation of the intubation and documentation of the same details.

Outcome Measures

Primary Outcome Measures

  1. 1st attempt success rate [Through study completion, anticipated 12-15 months]

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

Secondary Outcome Measures

  1. Complication rate [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 [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 [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 [Through study completion, anticipated 12-15 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Anesthesia Residents

  • SRNA

  • Pediatric Anesthesia Fellows

Exclusion Criteria:
  • Medical Students

  • Off-Service Rotators

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hopsital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

  • Principal Investigator: Stephen Flynn, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stephen Flynn, Attending Anesthesiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT04472195
Other Study ID Numbers:
  • IRB-P00034169
First Posted:
Jul 15, 2020
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2022