Extracorporeal Lung Assist to Avoid Intubation in Patients Failing NIV for Hypercapnic ARF (ECLAIR)
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ClinicalTrials.gov Identifier: NCT01784367 |
Recruitment Status
:
Completed
First Posted
: February 5, 2013
Last Update Posted
: June 19, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypercapnia Respiratory Insufficiency | Device: vv-ECCO2R (Novalung GmbH, Germany) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
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 |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: ECLA-group
Treatment with a pump driven, venovenous extracorporeal lung assist
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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.
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- Rate of intubation for invasive mechanical ventilation [ Time Frame: 21 days ]Rate of intubation for invasive mechanical ventilation
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784367
Germany | |
Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands) | |
Hamburg, Germany, 22399 |
Principal Investigator: | Stefan Kluge, MD | Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Stefan Kluge, PD Dr. Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT01784367 History of Changes |
Other Study ID Numbers: |
PV4190 |
First Posted: | February 5, 2013 Key Record Dates |
Last Update Posted: | June 19, 2017 |
Last Verified: | June 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 |