Status:
UNKNOWN
Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea
Lead Sponsor:
Technische Universität Dresden
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies s...
Eligibility Criteria
Inclusion
- Male and female patients 18 - 80 years;
- Clinical suspicion of an AIS (measurable or fluctuating neurological deficit with a National Institutes of Health Stroke Scale \[NIHSS\] ≥ 4 points) within 24 hours from symptom-onset;
- Extracranial (internal carotid artery) or intracranial (internal carotid artery; middle/anterior/posterior cerebral arteries) ≥ 50% stenosis, near-occlusion or occlusion diagnosed by ultrasound, computed tomography angiography (CTA) or magnetic resonance angiography (MRA), corresponding to acute neurological deficit;
- High-risk of having sleep apnea (classified by the Berlin sleep apnea questionnaire); or history of known sleep apnea; or witnessed repetitive apnea episodes during sleep or somnolence during hospitalization;
- Written informed consent by participants; alternatively by proxy or two physicians when not obtainable by patient or proxy (according to local regulations).
Exclusion
- Perceived course towards the malignant middle cerebral artery infarction;
- Immediate or perceived need for intubation;
- Known sleep apnea currently on non-invasive ventilatory treatment;
- Standard contraindications for non-invasive ventilatory treatment;
- Pre-morbid modified Rankin scale (mRS) score ≥ 3;
- Severe comorbidities (i.e., severe heart failure, severe obstructive lung disease, active malignant disease, severe dementia);
- Pregnant and breast feeding women;
- Participation in another clinical trial other than standard-of-care registry.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01812993
Start Date
March 1 2013
Last Update
February 12 2015
Active Locations (4)
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1
University of Tennessee Health Science Center, Department of Neurology
Memphis, Tennessee, United States, 38163
2
Department of Neurology, General Hospital Linz (AKH)
Linz, Austria
3
International Clinical Research Center, St. Anne's University Hospital Brno
Brno, Czechia
4
Dresden University Stroke Center, University of Technology Dresden,
Dresden, Germany