Clinical trial NCT01784367: Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Hypercapnic ARF
Official title: Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Respiratory Insufficiency
Keywords: Hypercapnia
noninvasive ventilation
acute respiratory failure
endotracheal intubation
invasive mechanical ventilation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Need for Intubation for Invasive Mechanical Ventilation
timeFrame: 21 days
Secondary outcomes:
measure: Length of Non-invasive Ventilation
timeFrame: 90 days
measure: Complication Rates
timeFrame: 90 days
measure: Length of Invasive Mechanical Ventilation if Intubated
timeFrame: 90 days
measure: Length of Stay in ICU
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands)
Study officials:
affiliation: Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf
name: Stefan Kluge, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/s00134-012-2649-2. Epub 2012 Jul 27.
citation: 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.