Asthma Clinical Trial
Official title:
Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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