Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

balloon fiber respiratory oxygenator Heart Failure ARDS COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hattler Respiratory Assist Catheter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven Tsui, MD

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Papworth Hospital NHS Trust

Papworth Everard, Cambridge, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04/Q0104/125

Identifier Type: -

Identifier Source: org_study_id