Reversal of the neurological deficit in acute stroke with the signal of efficacy trial of auto-BPAP to limit damage from suspected sleep apnea (Reverse-STEAL): study protocol for a randomized controlled trial

Trials

Andrei V Alexandrov²  Ulf Bodechtel³  Robert Mikulik⁵  Milan Vosko⁴  Anne W Alexandrov²  Karen C Albright²  Heinz Reichmann³  Volker Puetz³  Charlotte Zerna³  April Sisson²  Uta Schwanebeck¹  Xina Graehlert¹  Wiebke Schrempf³  Lars-Peder Pallesen³  Reza Bavarsad Shahripour²  Stanislava Kolieskova⁵  Kristian Barlinn⁵  Jessica Kepplinger³ 

[1] Coordination Center for Clinical Studies, University of Technology Dresden, Fetscherstrasse 74, Dresden 01307, Germany;Comprehensive Stroke Center, University of Alabama Hospital, 1813 Sixth Avenue South, RWUH M226, Birmingham, AL 35249, USA;Department of Neurology, University of Technology Dresden, Fetscherstrasse 74, Dresden 01307, Germany;Department of Neurology, General Hospital Linz (AKH), Krankenhausstrasse 9, Linz 4021, Austria;International Clinical Research Center, St. Anne’s University Hospital Brno, Pekarska 53, Brno, 656 91, Czech Republic

关键词: Early neurological deterioration;    BPAP;    Non-invasive ventilatory treatment;    Sleep apnea;    Stroke;   

Others  :  1093254
DOI  :  10.1186/1745-6215-14-252

 received in 2013-05-10, accepted in 2013-08-07,  发布年份 2013

【 摘 要 】

Background

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 have shown its tolerability and safety, yet no controlled randomized sequential phase studies exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients.

Methods/design

We decided to examine our hypothesis that early non-invasive ventilation with auto-titrating bilevel positive airway pressure (auto-BPAP) positively affects short-term clinical outcomes in AIS patients. We perform a multicenter, prospective, randomized, controlled, third rater- blinded, parallel-group trial. Patients with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard stroke care alone or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated within 24 hours of stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. Patients will undergo unattended cardiorespiratory polygraphy between days three and five to assess sleep apnea. Our primary endpoint will be any early neurological improvement on the NIHSS at 72 hours from randomization. Safety, tolerability, short-term and three-months functional outcomes will be assessed as secondary endpoints by un-blinded and blinded observers respectively.

Discussion

We expect that this study will advance our understanding of how early treatment with non-invasive ventilation can counterbalance, or possibly reverse, the deleterious effects of sleep apnea in the acute phase of ischemic stroke. The study will provide preliminary data to power a subsequent phase III study.

Trial registration

Clinicaltrials.gov Identifier: NCT01812993

【 授权许可】

   
2013 Kepplinger et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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