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

U

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)

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems