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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Hypercapnia; Respiratory Insufficiency

Treatments: Device: vv-ECCO2R (Novalung GmbH, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT01784367

PV4190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ECLA-group

Experimental group

Description:

Treatment with a pump driven, venovenous extracorporeal lung assist

Treatment:

Device: vv-ECCO2R (Novalung GmbH, Germany)