Simulation Training for Tracheostomy Care in Children

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new simulation training program for caregivers of children with tracheostomies (a tube in the neck to assist with breathing). The goal is to determine if this realistic practice can help caregivers manage emergencies at home, potentially reducing hospital visits. Participants will be divided into groups: one receiving standard education, another using high-tech simulation, and a third with simpler simulation. Caregivers new to caring for a child with a tracheostomy, especially those being discharged from intensive care for the first time, might be suitable candidates. As an unphased trial, this study offers caregivers the chance to gain valuable skills that could enhance their confidence and effectiveness in emergencies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this simulation training is safe for tracheostomy care in children?

Research has shown that simulation-based training is safe and well-tolerated. Studies have found that using life-like dolls in training helps caregivers practice real-life situations without risking patient safety. These practice sessions often include scenarios like a tube coming loose or equipment malfunctioning, allowing caregivers to respond without facing actual emergencies.

Typically, no negative events are linked to this type of training. The goal is to improve skills and confidence in handling critical situations, not to endanger participants. Overall, simulation training effectively prepares caregivers for real-world challenges.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve tracheostomy care training for caregivers of children. Unlike traditional education methods, which rely on basic instructions and demonstrations, this trial introduces a highly realistic simulation using advanced mannequins and audiovisual devices to mimic real-life emergencies. This immersive training aims to better prepare caregivers for unexpected situations, potentially enhancing their confidence and competence in managing tracheostomies at home. Additionally, the use of both high-fidelity and low-fidelity simulations allows researchers to compare the effectiveness of different training intensities, providing valuable insights that could revolutionize caregiver education in the future.

What evidence suggests that this simulation training is effective for tracheostomy care in children?

Research has shown that learning through practice can significantly boost caregivers' confidence and skills in managing tracheostomy emergencies. In this trial, participants in the active study group will engage in highly realistic simulation training, using a tracheostomy mannequin and audiovisual devices to mimic emergent clinical situations. Caregivers who participated in similar practice training reported feeling more satisfied and better prepared for home emergencies. Specifically, another study found that realistic practice scenarios enhanced caregivers' competence, leading to improved patient outcomes. These findings suggest that practice training, like the simulation training in this trial, could effectively prepare caregivers for real-life tracheostomy situations.34678

Who Is on the Research Team?

JH

Jennifer Henningfeld, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for caregivers who are looking after a child with a tracheostomy being discharged from the NICU/PICU for the first time. It includes 30 patients and their 60 caregivers, who must be able to read and speak English. Caregivers with experience caring for a child with a tracheostomy in the last 10 years cannot participate.

Inclusion Criteria

I am a caregiver for a patient with a tracheostomy leaving the NICU/PICU for the first time.

Exclusion Criteria

Caregivers cannot have cared for a child with a tracheostomy in the last 10 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Simulation Training

Caregivers undergo bedside education, classroom-based skills class, and simulation training (high-fidelity or low-fidelity) to prepare for discharge.

4 weeks
Multiple sessions (in-person)

Independent Care Sessions

Caregivers demonstrate practical skills needed for home care, repeating sessions until all skills are passed.

Up to 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after discharge, including surveys and performance assessments.

1 year
Regular follow-up visits and surveys

What Are the Treatments Tested in This Trial?

Interventions

  • Simulation
Trial Overview The study is testing a simulation program designed to help caregivers manage emergencies related to children dependent on tracheostomies and home ventilators. The goal is to see if realistic training can reduce hospital visits by improving understanding of potential clinical situations.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Active studyExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
Group III: Active controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Children's Wisconsin

Collaborator

Trials
3
Recruited
500+

Children's Hospital and Health System Foundation, Wisconsin

Collaborator

Trials
56
Recruited
93,300+

Citations

1.aao-hnsfjournals.onlinelibrary.wiley.comaao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.1276
Outcomes of Children With Tracheostomy Before and After ...“When in doubt, change it out”: a case-based simulation for pediatric residents caring for hospitalized tracheostomy-dependent children.
Assessing and enhancing pediatric residents' knowledge and ...This study assessed pediatric residents' tracheostomy care skills, found they were limited, and showed a workshop significantly increased their ...
Sim-Based Home Tracheostomy Care: A Mixed Methods ...To assess effects of a Simulation-Based Discharge Education Program (SDP) on long-term caregiver-reported satisfaction and to compare clinical outcomes.
Simulation Training in the Pediatric Tracheostomy and ...The investigators will develop, refine and pilot a highly-realistic simulation program that will allow caregivers opportunities to manage critical ...
Efficacy of Simulation for Caregivers of Children With a ...This study aimed to show simulation improves confidence and competence in caregivers of children with a tracheostomy and examined the impact on patient ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34702770/
Pediatric Tracheostomy Care Simulation: Real-Life ...The simulation program used a manikin to improve skills for real-life scenarios, including dislodgement, plugging, cardiac arrest, and ...
The impact of simulation-based training in medical educationThis article explores the impact of SBT, tracing its historical development and examining the various types of simulations utilized today, ...
Pediatric Tracheostomy Care Simulation: Real-Life ...Emergency scenarios included accidental tracheostomy tube dislodgement, tracheostomy tube plugging, cardiac arrest, and ventilator failure. Classes were ...
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