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Completed

NCT Number: NCT03223168

Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

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

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Key information

Conditions

Failing Fontan Physiology Pediatric Congenital Heart Disease

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of MIchigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Patients which will likely require intubation for catheterization
  • Severely depressed systemic ventricular systolic function
  • Baseline airway obstruction
  • Plastic bronchitis
  • Significant OUTFLOW obstruction

Treatment and study plan

Hayek RTX ventilator

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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