Use of the Hattler Respiratory Assist Catheter in Severe Respiratory Failure

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00288964
• Other study ID #: 04/Q0104/125
• Status: Withdrawn
• Phase: Phase 3
• First received: February 7, 2006
• Last updated: December 28, 2015
• Start date: November 2005

Study information

• Verified date: December 2015
• Source: Alung Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Asthma
• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Device:
• Hattler Respiratory Assist Catheter

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Trust	Papworth Everard	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Alung Technologies

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective insertion and removal as measured by hemostasis
Primary	Amount of effort required for both insertion and removal
Secondary	Peak gas exchange status within a maximum 7 day study