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Extracorporeal Lung Assist to Avoid Intubation in Patients Failing NIV for Hypercapnic ARF (ECLAIR)
This study has been completed.
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
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
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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: No masking 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01784367
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 16, 2017