Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

December 28, 2015 updated by: Alung Technologies

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridge
      • Papworth Everard, Cambridge, United Kingdom, CB3 8RE
        • Papworth Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effective insertion and removal as measured by hemostasis
Amount of effort required for both insertion and removal

Secondary Outcome Measures

Outcome Measure
Peak gas exchange status within a maximum 7 day study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alung Technologies

Investigators

  • Principal Investigator: Steven Tsui, MD, Papworth Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/Q0104/125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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