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Extracorporeal Lung Assist to Avoid Intubation in Patients Failing NIV for Hypercapnic ARF (ECLAIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01784367
First received: January 30, 2013
Last updated: June 16, 2017
Last verified: June 2017
  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.

Condition Intervention
Hypercapnia Respiratory Insufficiency Device: vv-ECCO2R (Novalung GmbH, Germany)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Rate of intubation for invasive mechanical ventilation [ Time Frame: 21 days ]
    Rate of intubation for invasive mechanical ventilation


Secondary Outcome Measures:
  • Length of non-invasive ventilation [ Time Frame: 21 days ]
    Length of non-invasive ventilation

  • Complication rates [ Time Frame: 3 months ]
    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 ]
    Length of invasive mechanical ventilation if intubated

  • Length of stay in ICU and hospital [ Time Frame: 3 months ]
    Length of stay in ICU and hospital

  • Mortality [ Time Frame: 3 months ]
    3-months-mortality

  • Changes in blood gases and respiratory rate pre/post start of ECLA [ Time Frame: 21 days ]
    Changes in arterial blood gases before and after the initiation of the pump driven extracorporeal lung assist


Enrollment: 30
Study Start Date: December 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECLA-group
Treatment with a pump driven, venovenous extracorporeal lung assist
Device: vv-ECCO2R (Novalung GmbH, Germany)
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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784367

Locations
Germany
Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands)
Hamburg, Germany, 22399
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: June 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2017