Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypercapnia
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Patients With Need for Intubation for Invasive Mechanical Ventilation
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Stefan Kluge
PD Dr. Stefan Kluge
Universitätsklinikum Hamburg-Eppendorf
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
Outcomes
Primary Outcomes
Number of Patients With Need for Intubation for Invasive Mechanical Ventilation
Time Frame: 21 days
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.
Secondary Outcomes
- Length of Non-invasive Ventilation(90 days)
- Mortality(90 days)
- Complication Rates(90 days)
- Length of Invasive Mechanical Ventilation if Intubated(90 days)
- Length of Stay in ICU(90 days)