Failing Fontan PhysiologyNCT03223168
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
A study testing Hayek RTX ventilator in people with Failing Fontan Physiology and Pediatric Congenital Heart Disease, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Failing Fontan Physiology, Pediatric Congenital Heart Disease
- What is being tested?
- Hayek RTX ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 19 Jul 2018
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).
Who cannot join
- Patients which will likely require intubation for catheterization
- Severely depressed systemic ventricular systolic function
- Baseline airway obstruction
- Plastic bronchitis
- Significant OUTFLOW obstruction
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators
- Being tested
- Hayek RTX ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hayek RTX ventilatorDevice
Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hayek RTX ventilator | Experimental | Participants will receive noninvasive negative pressure ventilation. Receives: Device: Hayek RTX ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics as characterized by change in pulmonary artery pressure
Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.
Measured: Baseline, 45 Minutes
Hemodynamics as characterized by change in pulmonary blood flow
Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.
Measured: Baseline, 45 Minutes
Hemodynamics as characterized by change in systemic arterial saturation
Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.
Measured: Baseline, 45 Minutes
Hemodynamics as characterized by change in cardiac output
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Measured: Baseline, 45 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start19 Jul 2017
- Primary completion13 Jun 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failing Fontan PhysiologyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peng, University of Michigan
- Investigators
- David Peng, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223168
- Sponsor's protocol ID
- HUM00131186
- Status last verified
- Oct 2019
- First submitted
- 17 Jul 2017
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
- ClinicalTrials.gov ID
- NCT03223168
- Acronym / sponsor ID
- HUM00131186
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 21 Jul 2017 (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 purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hayek RTX ventilator | Experimental | Device: Hayek RTX ventilatorParticipants will receive noninvasive negative pressure ventilation. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).
Key exclusion criteria (5 listed)
- Patients which will likely require intubation for catheterization
- Severely depressed systemic ventricular systolic function
- Baseline airway obstruction
- Plastic bronchitis
- Significant OUTFLOW obstruction
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 |
|---|---|---|
| Hayek RTX ventilatorParticipants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure. | Device | Hayek RTX ventilator |
Primary outcome
Hemodynamics as characterized by change in pulmonary artery pressure
Time frame: Baseline, 45 Minutes
Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in pulmonary blood flow
Time frame: Baseline, 45 Minutes
Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in systemic arterial saturation
Time frame: Baseline, 45 Minutes
Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in cardiac output
Time frame: Baseline, 45 Minutes
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
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.
David Peng, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hayek RTX ventilator in people with Failing Fontan Physiology and Pediatric Congenital Heart Disease, run by University of Michigan 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 1 inclusion and 5 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 7 Oct 2019. 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?
Hemodynamics as characterized by change in pulmonary artery pressure (time frame: Baseline, 45 Minutes). The study lists 4 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 7 Oct 2019.