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

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: 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:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

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


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
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: Name of device: iLA-Activve Manufacturer: Novalung GmbH, Germany

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:

Name of device: iLA-Activve
Manufacturer: 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.

Eligibility


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

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

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
Study First Received:	January 30, 2013
Last Updated:	July 13, 2015
Health Authority:	Germany: Ethics Commission

Keywords provided by 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 September 27, 2016

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