NCT00288964

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

First QC Date

February 7, 2006

Last Update Submit

December 28, 2015

Conditions

EmphysemaAcute Respiratory Distress SyndromeChronic Obstructive Pulmonary DiseaseAsthmaRespiratory Insufficiency

Keywords

balloonfiberrespiratoryoxygenatorHeart FailureARDSCOPD

Outcome Measures

Primary Outcomes (2)

  • Effective insertion and removal as measured by hemostasis

  • Amount of effort required for both insertion and removal

Secondary Outcomes (1)

  • Peak gas exchange status within a maximum 7 day study

Interventions

Hattler Respiratory Assist CatheterDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papworth Hospital NHS Trust

Papworth Everard, Cambridge, CB3 8RE, United Kingdom

Location

MeSH Terms

Conditions

EmphysemaRespiratory Distress SyndromePulmonary Disease, Chronic ObstructiveAsthmaRespiratory InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Diseases, ObstructiveChronic DiseaseDisease AttributesBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Steven Tsui, MD

    Papworth Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

November 1, 2005

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

GB(1)