NCT04472195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

July 8, 2020

Last Update Submit

January 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1st attempt success rate

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

    Through study completion, anticipated 12-15 months

Secondary Outcomes (4)

  • Complication rate

    Through study completion, anticipated 12-15 months

  • Self evaluation of neonate/infant laryngoscopy

    Through study completion, anticipated 12-15 months

  • Evaluation of utility of JIT/RCDP

    Through study completion, anticipated 12-15 months

  • Cognitive Load in intubating patient

    Through study completion, anticipated 12-15 months

Study Arms (2)

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

Control

NO INTERVENTION

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.

Interventions

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

Experimental

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesia Residents
  • SRNA
  • Pediatric Anesthesia Fellows

You may not qualify if:

  • Medical Students
  • Off-Service Rotators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Location

Related Publications (12)

  • Galvez JA, Acquah S, Ahumada L, Cai L, Polanski M, Wu L, Simpao AF, Tan JM, Wasey J, Fiadjoe JE. Hypoxemia, Bradycardia, and Multiple Laryngoscopy Attempts during Anesthetic Induction in Infants: A Single-center, Retrospective Study. Anesthesiology. 2019 Oct;131(4):830-839. doi: 10.1097/ALN.0000000000002847.

    PMID: 31335549BACKGROUND
  • Park RS, Rattana-Arpa S, Peyton JM, Huang J, Kordun A, Cravero JP, Zurakowski D, Kovatsis PG. Risk of Hypoxemia by Induction Technique Among Infants and Neonates Undergoing Pyloromyotomy. Anesth Analg. 2021 Feb 1;132(2):367-373. doi: 10.1213/ANE.0000000000004344.

    PMID: 31361669BACKGROUND
  • Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.

    PMID: 26705976BACKGROUND
  • Park R, Peyton JM, Fiadjoe JE, Hunyady AI, Kimball T, Zurakowski D, Kovatsis PG; PeDI Collaborative Investigators; PeDI collaborative investigators. The efficacy of GlideScope(R) videolaryngoscopy compared with direct laryngoscopy in children who are difficult to intubate: an analysis from the paediatric difficult intubation registry. Br J Anaesth. 2017 Nov 1;119(5):984-992. doi: 10.1093/bja/aex344.

    PMID: 29028952BACKGROUND
  • Else SDN, Kovatsis PG. A Narrative Review of Oxygenation During Pediatric Intubation and Airway Procedures. Anesth Analg. 2020 Apr;130(4):831-840. doi: 10.1213/ANE.0000000000004403.

    PMID: 31567323BACKGROUND
  • Hunt EA, Duval-Arnould JM, Nelson-McMillan KL, Bradshaw JH, Diener-West M, Perretta JS, Shilkofski NA. Pediatric resident resuscitation skills improve after "rapid cycle deliberate practice" training. Resuscitation. 2014 Jul;85(7):945-51. doi: 10.1016/j.resuscitation.2014.02.025. Epub 2014 Mar 4.

    PMID: 24607871BACKGROUND
  • Ericsson KA. Acquisition and maintenance of medical expertise: a perspective from the expert-performance approach with deliberate practice. Acad Med. 2015 Nov;90(11):1471-86. doi: 10.1097/ACM.0000000000000939.

    PMID: 26375267BACKGROUND
  • Ericsson KA and Pool R. Peak: Secrets From the New Science of Expertise. Boston, Mass. Houghton Mifflin Harcourt; 2016.

    BACKGROUND
  • Braga MS, Tyler MD, Rhoads JM, Cacchio MP, Auerbach M, Nishisaki A, Larson RJ. Effect of just-in-time simulation training on provider performance and patient outcomes for clinical procedures: a systematic review. BMJ Simul Technol Enhanc Learn. 2015 Oct 5;1(3):94-102. doi: 10.1136/bmjstel-2015-000058. eCollection 2015.

    PMID: 35515199BACKGROUND
  • Kessler D, Pusic M, Chang TP, Fein DM, Grossman D, Mehta R, White M, Jang J, Whitfill T, Auerbach M; INSPIRE LP investigators. Impact of Just-in-Time and Just-in-Place Simulation on Intern Success With Infant Lumbar Puncture. Pediatrics. 2015 May;135(5):e1237-46. doi: 10.1542/peds.2014-1911. Epub 2015 Apr 13.

    PMID: 25869377BACKGROUND
  • Nishisaki A, Donoghue AJ, Colborn S, Watson C, Meyer A, Brown CA 3rd, Helfaer MA, Walls RM, Nadkarni VM. Effect of just-in-time simulation training on tracheal intubation procedure safety in the pediatric intensive care unit. Anesthesiology. 2010 Jul;113(1):214-23. doi: 10.1097/ALN.0b013e3181e19bf2.

    PMID: 20526179BACKGROUND
  • Flynn SG, Park RS, Jena AB, Staffa SJ, Kim SY, Clarke JD, Pham IV, Lukovits KE, Huang SX, Sideridis GD, Bernier RS, Fiadjoe JE, Weinstock PH, Peyton JM, Stein ML, Kovatsis PG. Coaching inexperienced clinicians before a high stakes medical procedure: randomized clinical trial. BMJ. 2024 Dec 16;387:e080924. doi: 10.1136/bmj-2024-080924.

Study Officials

  • Stephen Flynn, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-crossover, Prospective Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 15, 2020

Study Start

August 1, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations