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Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population

NCT04308109 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-10-20

No results posted yet for this study

Summary

The investigators will develop, refine and pilot a highly-realistic simulation program that will allow caregivers opportunities to manage critical situations as it pertains to a medically complex child dependent on tracheostomy with or without home ventilation. The investigators hope to demonstrate that the use of highly realistic simulation training will improve hospital utilization as caregivers will have a more realistic understanding of clinical and equipment-related emergencies that may occur outpatient.

Conditions

  • Tracheostomy Complication
  • Simulation of Physical Illness
  • Teach-Back Communication

Interventions

BEHAVIORAL

Simulation

Simulation involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.

Sponsors & Collaborators

  • Children's Wisconsin

    collaborator UNKNOWN

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Jennifer Henningfeld, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2026-08-25
Completion
2026-08-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308109 on ClinicalTrials.gov