Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Hypercapnic ARF

NCT ID: NCT01784367

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Hypercapnia; Respiratory Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECLA-group

Treatment with a pump driven, venovenous extracorporeal lung assist

Group Type: EXPERIMENTAL

vv-ECCO2R (Novalung GmbH, Germany)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Stefan Kluge

PD Dr. Stefan Kluge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Kluge, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf

Locations

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

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 22836139 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27456703 (View on PubMed)

Related Links

http://www.uke.de

Department of principal investigator

Other Identifiers

PV4190

Identifier Type: -

Identifier Source: org_study_id