Tracheostomy ComplicationNCT04308109
Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population
A study testing Simulation in people with Tracheostomy Complication and Simulation of Physical Illness, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheostomy Complication, Simulation of Physical Illness, Teach-Back Communication
- What is being tested?
- Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be able to read and speak English
- Caring for a patient with a tracheostomy being discharged from the NICU/PICU for the first time
Who cannot join
- Can not have cared for a child with a tracheostomy in the last 10 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Wauwatosa, Wisconsin, 53226
About this study
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.
Read the detailed description
The investigators propose a prospective randomized control trial evaluating the use of simulation to prepare caregivers for the discharge of children dependent on respiratory technology. All caregivers of children who are (1) inpatient with a newly placed tracheostomy tube and (2) anticipated to start discharge teaching after the first date of Institutional Review Board (IRB) approval will be enrolled, regardless of home ventilator need. Caregivers with prior experience caring for tracheostomies within the last 10 years will be excluded. Estimated sample size is 60 caregivers (trainees) (2 trained caregivers anticipated per child). Trainees must be able to speak and read English.
All trainees will be randomized by child (up to 4 per child) into one of three arms (Figure 1), stratified by the need for invasive home ventilation and randomized in blocks of four. All trainees will complete our current state of education including bedside education provided by Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) nursing staff and a formal classroom-based skills class (either a 'tracheostomy-only' or a 'tracheostomy/home ventilator' class) taught by a Children's Hospital of Wisconsin (CHW) Tracheostomy and Home Ventilator respiratory therapist or durable medical equipment company (DME) respiratory therapist, and an individual scenario-based review of equipment and skills workshop with a CHW Tracheostomy and Home Ventilator Respiratory Therapist.
In addition to the current state of education, the active study group will also 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. 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. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the simulation instructor. After the simulation, participants will be debriefed by the instructor, who will use a tape of their session as a teaching tool.
Commonly encountered emergent outpatient problems to be simulated include 1) obstructed tracheostomy tube leading to the need for cardiopulmonary resuscitation; 2) bleeding from the tracheostomy tube; 3) acute desaturation and/or bradycardia; and 4) accidental decannulation. If invasive home ventilation is anticipated, ventilator alarm troubleshooting for high pressure alarms, low minute ventilation alarms, auto-cycling of the ventilator and water in the tubing will be included in the simulation.
All trainees will undergo a teach-back session with a CHW Tracheostomy and Home Ventilator Program respiratory therapist during which essential skills and responses to clinical situations are assessed. If a trainee passes this session, the respiratory therapist has determined that they have met criteria to move onto independent care sessions and the trainees have acquired the trach and home ventilator knowledge to provide care in the home. If a trainee fails this teach-back session, the information failed will be reviewed and the family will repeat the teach-back session until they pass and then move into independent care sessions. Independent care sessions are practical demonstrations of all skills needed to take care of the child at home. Independent care sessions are repeated until all skills have been passed. Teach-back and independent care sessions are part of the current state of education.
- Being tested
- Simulation
- Keywords
- Simulation, Teach-back, Caregiver
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No 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. |
| Active study | Experimental | 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. Receives: Behavioral: Simulation |
| Active control | Active comparator | 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. Receives: Behavioral: Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teach-back session performance
Difference in Teach-back performance between active study and control groups. Measured from 0-24, with higher scores being better.
Measured: Within 4 weeks of hospital discharge
Independent Care session performance
Independent Care performance between active study and control groups.
Measured: Within 4 weeks of hospital discharge
Hospital length of stay
Difference in hospital length of stay between active study and active control groups. Measured from 0-7, with higher scores being better.
Measured: First teaching session to discharge, an average of 4 weeks
Phone Calls
Difference in number of Phone Calls (from participants to medical providers/home care company) between active and control groups.
Measured: 1 year after initial discharge
Number of Hospital Re-admissions/Emergency Room (ER) visits
Difference in the number of Hospital Re-admissions/ER visit counts between active and control groups.
Measured: 1 year after initial discharge
Secondary outcomes (2)
Quality of discharge teaching scores
Quality of Discharge Teaching Scale measured on day of discharge; scale of 0 to 10; very high/very low scores indicate stronger opinions
Measured: Within 48 hours of initial hospital discharge
Caregiver post-discharge coping scores
Post Discharge Coping Difficulty Scale administered 24 hours after discharge and at first Tracheostomy/Home Ventilator clinic visit; scale of 0 to 10; very high/very low scores indicate stronger opinions
Measured: Scale administered 24 hours after discharge and about 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start22 Sep 2017
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Wisconsin
- Responsible party
- Principal investigator, Jennifer Henningfeld, Medical College of Wisconsin
- Investigators
- Jennifer Henningfeld, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308109
- Sponsor's protocol ID
- 979984
- Status last verified
- Oct 2025
- First submitted
- 16 Dec 2019
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population
- ClinicalTrials.gov ID
- NCT04308109
- Acronym / sponsor ID
- 979984
- Keywords
- Simulation, Teach-back, Caregiver
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Wisconsin
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose a prospective randomized control trial evaluating the use of simulation to prepare caregivers for the discharge of children dependent on respiratory technology. All caregivers of children who are (1) inpatient with a newly placed tracheostomy tube and (2) anticipated to start discharge teaching after the first date of Institutional Review Board (IRB) approval will be enrolled, regardless of home ventilator need. Caregivers with prior experience caring for tracheostomies within the last 10 years will be excluded. Estimated sample size is 60 caregivers (trainees) (2 trained caregivers anticipated per child). Trainees must be able to speak and read English.
All trainees will be randomized by child (up to 4 per child) into one of three arms (Figure 1), stratified by the need for invasive home ventilation and randomized in blocks of four. All trainees will complete our current state of education including bedside education provided by Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) nursing staff and a formal classroom-based skills class (either a 'tracheostomy-only' or a 'tracheostomy/home ventilator' class) taught by a Children's Hospital of Wisconsin (CHW) Tracheostomy and Home Ventilator respiratory therapist or durable medical equipment company (DME) respiratory therapist, and an individual scenario-based review of equipment and skills workshop with a CHW Tracheostomy and Home Ventilator Respiratory Therapist.
In addition to the current state of education, the active study group will also 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. 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. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the simulation instructor. After the simulation, participants will be debriefed by the instructor, who will use a tape of their session as a teaching tool.
Commonly encountered emergent outpatient problems to be simulated include 1) obstructed tracheostomy tube leading to the need for cardiopulmonary resuscitation; 2) bleeding from the tracheostomy tube; 3) acute desaturation and/or bradycardia; and 4) accidental decannulation. If invasive home ventilation is anticipated, ventilator alarm troubleshooting for high pressure alarms, low minute ventilation alarms, auto-cycling of the ventilator and water in the tubing will be included in the simulation.
All trainees will undergo a teach-back session with a CHW Tracheostomy and Home Ventilator Program respiratory therapist during which essential skills and responses to clinical situations are assessed. If a trainee passes this session, the respiratory therapist has determined that they have met criteria to move onto independent care sessions and the trainees have acquired the trach and home ventilator knowledge to provide care in the home. If a trainee fails this teach-back session, the information failed will be reviewed and the family will repeat the teach-back session until they pass and then move into independent care sessions. Independent care sessions are practical demonstrations of all skills needed to take care of the child at home. Independent care sessions are repeated until all skills have been passed. Teach-back and independent care sessions are part of the current state of education.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No 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. |
| Active study | Experimental | Behavioral: SimulationIn 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. |
| Active control | Active comparator | Behavioral: SimulationIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be able to read and speak English
- Caring for a patient with a tracheostomy being discharged from the NICU/PICU for the first time
Key exclusion criteria (1 listed)
- Can not have cared for a child with a tracheostomy in the last 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulationSimulation 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. | Behavioural | Active control, Active study |
Primary outcome
Teach-back session performance
Time frame: Within 4 weeks of hospital discharge
Difference in Teach-back performance between active study and control groups. Measured from 0-24, with higher scores being better.
Independent Care session performance
Time frame: Within 4 weeks of hospital discharge
Independent Care performance between active study and control groups.
Hospital length of stay
Time frame: First teaching session to discharge, an average of 4 weeks
Difference in hospital length of stay between active study and active control groups. Measured from 0-7, with higher scores being better.
Phone Calls
Time frame: 1 year after initial discharge
Difference in number of Phone Calls (from participants to medical providers/home care company) between active and control groups.
Number of Hospital Re-admissions/Emergency Room (ER) visits
Time frame: 1 year after initial discharge
Difference in the number of Hospital Re-admissions/ER visit counts between active and control groups.
2 secondary outcomes
Quality of discharge teaching scores
Time frame: Within 48 hours of initial hospital discharge
Caregiver post-discharge coping scores
Time frame: Scale administered 24 hours after discharge and about 1 month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Tracheostomy Complication
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
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Increased Body Temperature Post Tracheostomy: a Retrospective Study
Tracheostomy Complication
RecruitingObservational study
Outcomes After Tracheal Cannula Removal
Tracheostomy
RecruitingObservational study
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
Anesthesia Complication, Tracheostomy Complications
RecruitingObservational study
"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
Surveillance, Endoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Henningfeld, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation in people with Tracheostomy Complication and Simulation of Physical Illness, run by Medical College of Wisconsin 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Teach-back session performance (time frame: Within 4 weeks of hospital discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2025.