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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hayek RTX ventilator
Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.

Locations

Country Name City State
United States University of MIchigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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
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