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Simulation Training for Tracheostomy Care in Children

N/A

Waitlist Available

Led By Jennifer Henningfeld, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Caregivers must be able to read and speak English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up scale administered 24 hours after discharge and about 1 month after discharge

Awards & highlights

Study Summary

This trial will help researchers understand if simulation training can help caregivers manage critical situations with kids who need a tracheostomy or home ventilation.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves educational simulation training rather than medical or drug interventions, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My caregiver can read and speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ scale administered 24 hours after discharge and about 1 month after discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~scale administered 24 hours after discharge and about 1 month after discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and scale administered 24 hours after discharge and about 1 month after discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospital length of stay

Independent Care session performance

Number of Hospital Re-admissions/Emergency Room (ER) visits

+2 more

Secondary outcome measures

Caregiver post-discharge coping scores

Quality of discharge teaching scores

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Active studyExperimental Treatment1 Intervention

In addition to the current state of education, the active study group will undergo highly realistic simulation. This 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. Caregivers will complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.

Group II: ControlActive Control1 Intervention

No intervention, the same as the current state of education. Caregivers will still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.

Group III: Active controlActive Control1 Intervention

In addition to the current state of education, the active control will undergo low-fidelity simulation that approximates the highly realistic clinical scenarios except with the use of a low-fidelity doll equipped with a tracheostomy and without the audiovisual inputs. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simulation

2021

N/A

~580

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,537 Total Patients Enrolled

Children's Hospital and Health System Foundation, WisconsinOTHER

55 Previous Clinical Trials

96,585 Total Patients Enrolled

Jennifer Henningfeld, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Simulation Clinical Trial Eligibility Overview. Trial Name: NCT04308109 — N/A

Malingering Research Study Groups: Control, Active study, Active control

Malingering Clinical Trial 2023: Simulation Highlights & Side Effects. Trial Name: NCT04308109 — N/A

Simulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04308109 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have recruitment efforts for this scientific exploration begun?

"The clinical trial listed on clinicaltrials.gov is not accepting new participants as of April 11th, 2022; however, there are currently 7 other studies that may seek volunteers. This medical experiment was initially advertised on September 22nd 2017 and its last edit was made recently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population

Jennifer Henningfeld 2017. "Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04308109.