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

NCT01784367 | Completed Results DMC

• 1 other identifier: PV4190
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercapnia; Respiratory Insufficiency

Keywords

Hypercapnia; noninvasive ventilation; acute respiratory failure; endotracheal intubation; invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Need for Intubation for Invasive Mechanical Ventilation

  The number of patients in the ECLA-group who had to be intubated and mechanically ventilated under the given criteria for inclusion and exclusion is collected. Since every patient in the matched control group was intubated, the comparison of the groups shows whether the use of a pump-driven venovenous extracorporeal lung assist can reduce the frequency of intubation and mechanical ventilation.

  21 days

Secondary Outcomes (5)

• Length of Non-invasive Ventilation

  90 days

• Complication Rates

  90 days

• Length of Invasive Mechanical Ventilation if Intubated

  90 days

• Length of Stay in ICU

  90 days

• Mortality

  90 days

Study Arms (1)

ECLA-group

EXPERIMENTAL

Treatment with a pump driven, venovenous extracorporeal lung assist

Device: vv-ECCO2R (Novalung GmbH, Germany)

Interventions

vv-ECCO2R (Novalung GmbH, Germany) 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.

ECLA-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute or acute-on-chronic hypercapnic respiratory insufficiency (pH ≤ 7,35, PaCO2 \> 45 mmHg)
• failure of noninvasive ventilation
• fulfilling criteria for endotracheal intubation

You may not qualify if:

• under 18 years of age
• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 22399, Germany

Location

Related Publications (2)

• 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.

  PMID: 22836139 BACKGROUND

• 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.

  PMID: 27456703 RESULT

Related Links

• Department of principal investigator

MeSH Terms

Conditions

Hypercapnia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

An important methodological limitation of our study is that the criteria used to define "NIV failure" and "indication for intubation" in the ECCO 2R group left a degree of subjective clinical judgement to the attending intensivist.

Results Point of Contact

• Title: Prof. Dr. Stefan Kluge
• Organization: University Medical Center Hamburg-Eppendorf, Germany

skluge@uke.de

+49-40-7410

Study Officials

• Stefan Kluge, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Stefan Kluge

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 5, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)