Pediatric Congenital Heart Disease Clinical Trial
Official title:
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
NCT number | NCT03223168 |
Other study ID # | HUM00131186 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 19, 2017 |
Est. completion date | July 19, 2018 |
Verified date | October 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 10 |
Est. completion date | July 19, 2018 |
Est. primary completion date | June 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: 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). Exclusion Criteria: 1. Patients which will likely require intubation for catheterization 2. Severely depressed systemic ventricular systolic function 3. Baseline airway obstruction 4. Plastic bronchitis 5. Significant OUTFLOW obstruction |
Country | Name | City | State |
---|---|---|---|
United States | University of MIchigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 45 Minutes | |
Primary | 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. | Baseline, 45 Minutes | |
Primary | 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. | Baseline, 45 Minutes | |
Primary | 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 | Baseline, 45 Minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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