Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure (ECLAIR)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2014 by Universitätsklinikum Hamburg-Eppendorf
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: November 1, 2014
Last verified: November 2014
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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. 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: | August 2015 |
| Estimated Primary Completion Date: | April 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:
|
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
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
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: | November 1, 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:
|
Hypoventilation Respiratory Insufficiency Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory |
ClinicalTrials.gov processed this record on March 03, 2015