Clinical Trial: Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
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 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. 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.
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Current Primary Outcome: Rate of intubation for invasive mechanical ventilation [ Time Frame: 21 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of non-invasive ventilation [ Time Frame: 21 days ]
- Complication rates [ Time Frame: 3 months ]Any complication associated with the pump driven extracorporeal lung assist device or with non-invasive or invasive mechanical ventilation or any associated treatments during the observational period
- Length of invasive mechanical ventilation if intubated [ Time Frame: 3 months ]
- Length of stay in ICU and hospital [ Time Frame: 3 months ]
- Mortality [ Time Frame: 3 months ]
- Changes in blood gases and respiratory rate pre/post start of ECLA [ Time Frame: 21 days ]Changes in arterial blood gases before and after the initiation of the pump driven extracorporeal lung assist
Original Secondary Outcome: Same as current
Information By: Universitätsklinikum Hamburg-Eppendorf
Dates:
Date Received: January 30, 2013
Date Started: December 2012
Date Completion:
Last Updated: July 13, 2015
Last Verified: July 2015
