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

Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Hypercapnia
• Intervention / Treatment: Device: vv-ECCO2R (Novalung GmbH, Germany)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22399
    • Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intubation for invasive mechanical ventilation	Rate of intubation for invasive mechanical ventilation	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of non-invasive ventilation	Length of non-invasive ventilation	21 days
Complication rates	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 months
Length of invasive mechanical ventilation if intubated	Length of invasive mechanical ventilation if intubated	3 months
Length of stay in ICU and hospital	Length of stay in ICU and hospital	3 months
Mortality	3-months-mortality	3 months
Changes in blood gases and respiratory rate pre/post start of ECLA	Changes in arterial blood gases before and after the initiation of the pump driven extracorporeal lung assist	21 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Stefan Kluge, MD, Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf

Publications and helpful links

General 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. doi: 10.1007/s00134-012-2649-2. Epub 2012 Jul 27.
• 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.

Helpful Links

• Department of principal investigator

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 30, 2013
• First Submitted That Met QC Criteria: February 2, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: endotracheal intubation; noninvasive ventilation; Hypercapnia; acute respiratory failure; invasive mechanical ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: PV4190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No