Clinical Trial: Continuous Positive Airway Pressure Ventilation After Acute Ischemic Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Feasibility and Efficacy Study of Early Continuous Positive Airway Pressure Ventilation in Patients With Acute Ischemic Stroke
Brief Summary:
More than half of all stroke patients have sleep apneas in the acute phase after stroke. Sleep apneas may be associated with higher degrees of disability three months after stroke due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac arrhythmias, and clotting disorders.
Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these effects very shortly after initiation. The aim of the study is to test the feasibility of early non-invasive CPAP treatment starting in the first night after stroke onset, and to test its efficacy in a randomized clinical trial.
50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard care PLUS CPAP treatment or standard care only. All patients randomized to the intervention group will receive CPAP therapy for the first three nights after stroke. In the fourth night, a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned to the intervention group with a respiratory distress index > 10/h will be treated further on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be performed to determine the size of the infarction. The NIHSS score will be used to assess clinical short-term outcome on day 4 and day 10. After three months, the outcome will be determined using the modified Rankin scale.
As CPAP therapy may be more laborious for the provider, the additional work-load will be documented using pre-specified scales.
Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients and that the additional work load will not outweigh the benefits.
Secondary
Detailed Summary:
Sponsor: University Hospital Muenster
Current Primary Outcome: Primary endpoint is to test the feasibility of early non-invasive CPAP ventilation in acute stroke patients
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Size of brain infarction on diffusion weighted MRI imaging at day 10 after symptom onset
- Disability measured by the modified Rankin scale after three months
Original Secondary Outcome: Same as current
Information By: University Hospital Muenster
Dates:
Date Received: September 7, 2005
Date Started: April 2005
Date Completion:
Last Updated: November 23, 2010
Last Verified: April 2008
