Reversal of the neurological deficit in acute stroke with the signal of efficacy trial of auto-BPAP to limit damage from ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2013-12

AUTHORS

Jessica Kepplinger, Kristian Barlinn, Stanislava Kolieskova, Reza Bavarsad Shahripour, Lars-Peder Pallesen, Wiebke Schrempf, Xina Graehlert, Uta Schwanebeck, April Sisson, Charlotte Zerna, Volker Puetz, Heinz Reichmann, Karen C Albright, Anne W Alexandrov, Milan Vosko, Robert Mikulik, Ulf Bodechtel, Andrei V Alexandrov

ABSTRACT

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. More... »

PAGES

252

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-14-252

DOI

http://dx.doi.org/10.1186/1745-6215-14-252

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1048385756

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23941576


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