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Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Alung Technologies
ClinicalTrials.gov Identifier:
NCT00288964
First received: February 7, 2006
Last updated: August 13, 2009
Last verified: August 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 20
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00288964     History of Changes
Other Study ID Numbers: 04/Q0104/125
Study First Received: February 7, 2006
Last Updated: August 13, 2009
Health Authority: United Kingdom: Department of Health

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

Additional relevant MeSH terms:
Asthma
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Insufficiency
Lung Diseases, Obstructive
 Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on May 16, 2013