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Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

This study has been withdrawn prior to enrollment.
(Sponsor no longer pursuing regulatory approval of investigational device)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288964
First Posted: February 9, 2006
Last Update Posted: December 29, 2015
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.
Information provided by:
Alung Technologies
  Purpose

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 Intervention Phase
Emphysema Acute Respiratory Distress Syndrome Chronic Obstructive Pulmonary Disease Asthma Respiratory Insufficiency Device: Hattler Respiratory Assist Catheter Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Alung Technologies:

Primary Outcome Measures:
  • Effective insertion and removal as measured by hemostasis
  • Amount of effort required for both insertion and removal

Secondary Outcome Measures:
  • Peak gas exchange status within a maximum 7 day study

Enrollment: 0
Study Start Date: November 2005
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Alung Technologies
Investigators
Principal Investigator: Steven Tsui, MD Papworth Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00288964     History of Changes
Other Study ID Numbers: 04/Q0104/125
First Submitted: February 7, 2006
First Posted: February 9, 2006
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Alung Technologies:
balloon
fiber
respiratory
oxygenator
Heart Failure
ARDS
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Emphysema
Acute Lung Injury
Pulmonary Valve Insufficiency
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pathologic Processes
Lung Injury
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases