Skip to content

Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

Compassionate Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure - A Clinical Trial

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00288964
Enrollment
0
Registered
2006-02-09
Start date
2005-11-30
Completion date
Unknown
Last updated
2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Asthma, Chronic Obstructive Pulmonary Disease, Emphysema, Respiratory Insufficiency

Keywords

balloon, fiber, respiratory, oxygenator, Heart Failure, ARDS, COPD

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.

Interventions

DEVICEHattler Respiratory Assist Catheter

Sponsors

Alung Technologies
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effective insertion and removal as measured by hemostasis
Amount of effort required for both insertion and removal

Secondary

MeasureTime frame
Peak gas exchange status within a maximum 7 day study

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026