Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure (ECLAIR)

This study is currently recruiting participants.
Verified February 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01784367
First received: January 30, 2013
Last updated: February 17, 2014
Last verified: February 2013
  Purpose

The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation. Since intubation with subsequent (prolonged) invasive mechanical ventilation is associated with considerable side effects this new strategy has the potential to improve overall clinical outcome in this selected patient group.


Condition Intervention
Hypercapnia
Respiratory Insufficiency
Device: ECLA (extracorporeal lung assist)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Rate of intubation for invasive mechanical ventilation [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of non-invasive ventilation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Complication rates [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Any complication associated with the pump driven extracorporeal lung assist device or with non-invasive or invasive mechanical ventilation or any associated treatments during the observational period

  • Length of invasive mechanical ventilation if intubated [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Length of stay in ICU and hospital [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in blood gases and respiratory rate pre/post start of ECLA [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Changes in arterial blood gases before and after the initiation of the pump driven extracorporeal lung assist


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ECLA-group
All patients included in the study receiving treatment with a pump driven, venovenous extracorporeal lung assist (ECLA)
Device: ECLA (extracorporeal lung assist)
Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation.
Other Names:
  • Name of device: iLA-Activve
  • Manufacturer: Novalung GmbH, Germany

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute or acute-on-chronic hypercapnic respiratory insufficiency (pH ≤ 7,35, PaCO2 > 45 mmHg)
  • failure of noninvasive ventilation
  • fulfilling criteria for endotracheal intubation

Exclusion Criteria:

  • under 18 years of age
  • prior inclusion in other interventional study
  • pregnancy
  • heparin allergy or heparin-induced thrombocytopenia type 2
  • on home non-invasive ventilator
  • "Do not resuscitate" order or moribund condition
  • life expectancy less than 6 months
  • no informed consent available
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784367

Contacts
Contact: Stefan Kluge, MD +4940741057010 skluge@uke.de
Contact: Stephan A Braune, MD, MPH +4915222817083 sbraune@uke.de

Locations
Germany
Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands) Recruiting
Hamburg, Germany, 22399
Contact: Stefan Kluge, MD    +49741057010    skluge@uke.de   
Contact: Stephan A Braune, MD, MPH    +4015222817083    sbraune@uke.de   
Principal Investigator: Stefan Kluge, MD         
Sub-Investigator: Stephan A Braune, MD, MPH         
Sub-Investigator: Axel Nierhaus, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Stefan Kluge, MD Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf
  More Information

Additional Information:
Publications:
Responsible Party: Stefan Kluge, PD Dr. Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01784367     History of Changes
Other Study ID Numbers: PV4190
Study First Received: January 30, 2013
Last Updated: February 17, 2014
Health Authority: Germany: Ethics commitee of the Medical Association Hamburg

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Hypercapnia
noninvasive ventilation
acute respiratory failure
endotracheal intubation
invasive mechanical ventilation

Additional relevant MeSH terms:
Hypercapnia
Respiratory Insufficiency
Hypoventilation
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014