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

Respiratory Insufficiency Clinical Trial

— ECLAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784367
• Other study ID #: PV4190
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: June 16, 2017
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 noninvasiv — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of intubation for invasive mechanical ventilation	Rate of intubation for invasive mechanical ventilation	21 days
Secondary	Length of non-invasive ventilation	Length of non-invasive ventilation	21 days
Secondary	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
Secondary	Length of invasive mechanical ventilation if intubated	Length of invasive mechanical ventilation if intubated	3 months
Secondary	Length of stay in ICU and hospital	Length of stay in ICU and hospital	3 months
Secondary	Mortality	3-months-mortality	3 months
Secondary	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

External Links

•   Department of principal investigator