Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2018-05-01

Brief Summary

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The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic". The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic circuit delivers oxygen-rich blood throughout the body. In children born with a single ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen levels in the blood delivered to the body (cyanosis).

The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made connection (whereby two large body veins \[cavae\] are sewn to the pulmonary arteries), thereby preventing mixing of blood through restoration of two distinct circuits without mixing of blood. Although the Fontan operation effectively eliminates cyanosis and enables survival into adulthood, increased systemic venous pressure is an unavoidable systemic complication and low cardiac output (CO) is pervasive finding.

Despite excellent pediatric surgical results, the risk of late complications and death dramatically increases in the decades following Fontan surgery. A chronically low CO state secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction and shortened life expectancy. Short of heart transplantation, deemed suitable only for a minority of patients, effective therapies for low CO are largely absent. The investigators aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO. Specifically, external suction is applied intermittently to the chest wall, much like a vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass® ventilator (Hayek Medical). Although used in patients with lung disease, the investigators' proposal is to evaluate this novel, portable, ventilation system would be the first study of its kind in adults with congenital heart disease, specifically those with a Fontan palliation.

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Detailed Description

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Conditions

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Fontan Physiology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a cross-sectional study designed to evaluate the immediate impact of negative pressure ventilation (NPV) in an ambulatory Fontan population using cardiovascular magnetic resonance imaging (CMR) for assessment of cardiovascular flows.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fontan patient population

Group Type ACTIVE_COMPARATOR

Hayek RTX ventilator

Intervention Type DEVICE

Negative pressure ventilation in Fontan patients.

Healthy volunteers

Group Type SHAM_COMPARATOR

Hayek RTX ventilator

Intervention Type DEVICE

Negative pressure ventilation in Fontan patients.

Interventions

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Hayek RTX ventilator

Negative pressure ventilation in Fontan patients.

Intervention Type DEVICE

Other Intervention Names

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Cuirass Negative pressure ventilation

Eligibility Criteria

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Inclusion Criteria

* Fontan patients age \> 13 years.

Exclusion Criteria

* unable to complete MRI (pacemaker/defibrillator/retained wires, pregnancy, claustrophobia);
* evidence of Fontan failure (requiring ongoing medical / device therapy) protein-losing enteropathy, intracardiac thrombus, anatomical obstruction to the Fontan circuit;
* patent Fontan fenestration;
* oxygen saturation \< 90%;
* ongoing arrhythmia;
* ejection fraction \< 50% on echocardiography or CMR;
* moderate or severe valve insufficiency on echocardiography or CMR;
* Obesity (BMI \>35);
* severe obstructive sleep apnea (AHI\>20);
* chronic obstructive lung disease (FEV1/FVC\<60%);
* severe chest wall deformities (scoliosis, kyphosis, kyphoscoliosis);
* acute or chronic kidney disease (eGFR\<60)
* unable to provide informed consent.

Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes