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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Hypercapnia; Respiratory Insufficiency	Device: vv-ECCO2R (Novalung GmbH, Germany)	Not Applicable

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.

Study Design

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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

Arms and Interventions

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Arm

Intervention/treatment

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.

Outcome Measures

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Primary Outcome Measures :

1. Rate of intubation for invasive mechanical ventilation [ Time Frame: 21 days ]
   Rate of intubation for invasive mechanical ventilation

Secondary Outcome Measures :

1. Length of non-invasive ventilation [ Time Frame: 21 days ]
   Length of non-invasive ventilation
2. 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
3. Length of invasive mechanical ventilation if intubated [ Time Frame: 3 months ]
   Length of invasive mechanical ventilation if intubated
4. Length of stay in ICU and hospital [ Time Frame: 3 months ]
   Length of stay in ICU and hospital
5. Mortality [ Time Frame: 3 months ]
   3-months-mortality
6. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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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

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Additional Information:

Department of principal investigator 

Publications of Results:

Braune S, Sieweke A, Brettner F, Staudinger T, Joannidis M, Verbrugge S, Frings D, Nierhaus A, Wegscheider K, Kluge S. The feasibility and safety of extracorporeal carbon dioxide removal to avoid intubation in patients with COPD unresponsive to noninvasive ventilation for acute hypercapnic respiratory failure (ECLAIR study): multicentre case-control study. Intensive Care Med. 2016 Sep;42(9):1437-44. doi: 10.1007/s00134-016-4452-y. Epub 2016 Jul 25.

Other Publications:

Kluge S, Braune SA, Engel M, Nierhaus A, Frings D, Ebelt H, Uhrig A, Metschke M, Wegscheider K, Suttorp N, Rousseau S. Avoiding invasive mechanical ventilation by extracorporeal carbon dioxide removal in patients failing noninvasive ventilation. Intensive Care Med. 2012 Oct;38(10):1632-9. Epub 2012 Jul 27.

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
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