Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

Study Overview
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Brief Summary
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A new artificial lung device has been developed that potentially provides added support to mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of up to 7 days, providing more time for the lungs to improve. Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a manner that is dependable and reproducible.

Detailed Description
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The Hattler Catheter Respiratory Assist Device consists of a Catheter and a drive console. The catheter consists of a bundle of polypropylene hollow fibers (approximately 1000) in 30cm or 35cm length surrounding a helium filled balloon. The balloon is similar to an Intra-Aortic Balloon, however, it is pulsed at 300 beats per minute, while IABP typically operate at 120 bpm. The hollow fibers are similar to fibers utilized in external oxygenators for cardio-pulmonary bypass. No device exists on the market in which fibers surround a balloon, and no device exists on the market in which the hollow fiber bundle is designed to be inserted into the venous system, i.e., the vena cava. External oxygenators are designed to be used in an extracorporeal circulatory loop. The Hattler Catheter drive console provides the power to drive the helium filled balloon while removing excess oxygen and carbon dioxide from the venous system via the catheter.

Official Title
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Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial

Conditions
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Emphysema, Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease, Asthma, Respiratory Insufficiency

Intervention / Treatment
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* Device: Hattler Respiratory Assist Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes, 18 years and older Have a terminally ill disease process On maximum ventilator support Intubated and unconscious Swan Ganz in place Hypoxic Unsuitable for organ donation Exclusion Criteria: Circulatory shock (< 80 mmHg) and unresponsive to drug therapy and volume replacement Pregnancy Morbid obesity > 182 kg Weight < 41 kg History of bleeding disorders with contraindication to heparin Have a disease process with a contraindication to heparin Known internal jugular or femoral vein complications or abnormalities Known inferior vena cava (IVC) filter in place

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hattler Respiratory Assist Catheter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective insertion and removal as measured by hemostasis |  |  | 
| Amount of effort required for both insertion and removal |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak gas exchange status within a maximum 7 day study |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, balloon, fiber, respiratory, oxygenator, Heart Failure, COPD