Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00288964|
Recruitment Status : Withdrawn (Sponsor no longer pursuing regulatory approval of investigational device)
First Posted : February 9, 2006
Last Update Posted : December 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Emphysema Acute Respiratory Distress Syndrome Chronic Obstructive Pulmonary Disease Asthma Respiratory Insufficiency||Device: Hattler Respiratory Assist Catheter||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial|
|Study Start Date :||November 2005|
- Effective insertion and removal as measured by hemostasis
- Amount of effort required for both insertion and removal
- Peak gas exchange status within a maximum 7 day study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288964
|Papworth Hospital NHS Trust|
|Papworth Everard, Cambridge, United Kingdom, CB3 8RE|
|Principal Investigator:||Steven Tsui, MD||Papworth Hospital|