Continuous Positive Airway Pressure Ventilation After Acute Ischemic Stroke
Condition: Brain Infarction
MeSH terms: Ischemic Stroke; Brain Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

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 hypothesis is that patients assigned to the treatment group have smaller
      infarctions on MRI and less neurological deficits at 3 months after stroke.

      Patients entering the study will be investigated by transcranial Doppler ultrasound in case
      they have sufficient temporal bone windows for insonation and no stenosis or occlusions of
      major brain supplying arteries by the time of investigation that disturb the intracerebral
      blood flow.

      All intracranial arteries will be assessed before treatment, after treatment and on day 8
      after the insult.

      Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new
      software algorithm developed by NHSi, to investigate microcirculatory information from the
      flow spectra of the major intracranial arteries.

      The data from this post-hoc analysis are compared with the data of the polysomnography and
      with treatment.

      Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea
      on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between
      treated patients and controls.
    


Intervention name(s): non-invasive continuous positive airway pressure ventilation; CPAP-treatment
Intervention type(s): Device; Device
Intervention description(s): night time CPAP-mask ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic stroke; CPAP ventilation