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AnesthesiaNCT04472195

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

A study testing Simulation Airway Coaching in people with Anesthesia, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Simulation Airway Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteUnited States
Study dates
1 Aug 2020to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Anesthesia Residents
  • SRNA
  • Pediatric Anesthesia Fellows

Who cannot join

  • Medical Students
  • Off-Service Rotators

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hopsital

    Boston, Massachusetts, 02115

Other trials in United States

About this 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.

Read the 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.

Conditions
Anesthesia
Being tested
Simulation Airway Coaching

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation Airway CoachingOther

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

Study groups in NCT04472195
Study groupRoleWhat they receive
ExperimentalExperimentalThe 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.
Receives: Other: Simulation Airway Coaching
ControlNo interventionThe trainees in the control group will have no interventions by the research team, only observation of the intubation and documentation of the same details.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1st attempt success rate

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

    Measured: Through study completion, anticipated 12-15 months

Secondary outcomes (4)

  1. Complication rate

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

    Measured: Through study completion, anticipated 12-15 months

  2. Self evaluation of neonate/infant laryngoscopy

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

    Measured: Through study completion, anticipated 12-15 months

  3. Evaluation of utility of JIT/RCDP

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

    Measured: Through study completion, anticipated 12-15 months

  4. Cognitive Load in intubating patient

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

    Measured: Through study completion, anticipated 12-15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2020
  2. Study start1 Aug 2020
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Non-crossover, Prospective Randomized Controlled Trial
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04472195
Sponsor's protocol ID
IRB-P00034169
Status last verified
Jan 2025
First submitted
8 Jul 2020
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31335549

  • 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.

    PubMed 31361669

  • 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.

    PubMed 26705976

  • 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.

    PubMed 29028952

  • 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.

    PubMed 31567323

  • 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.

    PubMed 24607871

  • 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.

    PubMed 26375267

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

  • 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.

    PubMed 35515199

  • 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.

    PubMed 25869377

  • 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.

    PubMed 20526179

  • 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.

    PubMed 39681397

Questions about this trial

What is this clinical trial studying?

A study testing Simulation Airway Coaching in people with Anesthesia, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1st attempt success rate (time frame: Through study completion, anticipated 12-15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04472195, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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