Clinical trial NCT00288964: Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure
Official title: Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Emphysema
Acute Respiratory Distress Syndrome
Chronic Obstructive Pulmonary Disease
Asthma
Respiratory Insufficiency
Keywords: balloon
fiber
respiratory
oxygenator
Heart Failure
ARDS
COPD
Lead sponsor: Alung Technologies
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
measure: Effective insertion and removal as measured by hemostasis
measure: Amount of effort required for both insertion and removal
Secondary outcomes:
measure: Peak gas exchange status within a maximum 7 day study
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Trust
state: Cambridge
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Steven Tsui, MD
role: PRINCIPAL_INVESTIGATOR
References: