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

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

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Article number252
JournalTrials
Volume14
Issue number1
DOIs
StatePublished - Aug 13 2013

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Sleep Apnea Syndromes
Randomized Controlled Trials
Stroke
Pressure
Noninvasive Ventilation
Safety
Random Allocation
Sleep

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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

In: Trials, Vol. 14, No. 1, 252, 13.08.2013.

Research output: Contribution to journalArticle

Kepplinger, J, Barlinn, K, Kolieskova, S, Shahripour, RB, Pallesen, LP, Schrempf, W, Graehlert, X, Schwanebeck, U, Sisson, A, Zerna, C, Puetz, V, Reichmann, H, Albright, KC, Alexandrov, A, Vosko, M, Mikulik, R, Bodechtel, U & Alexandrov, A 2013, '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, vol. 14, no. 1, 252. https://doi.org/10.1186/1745-6215-14-252
Kepplinger, Jessica ; Barlinn, Kristian ; Kolieskova, Stanislava ; Shahripour, Reza B. ; Pallesen, Lars Peder ; Schrempf, Wiebke ; Graehlert, Xina ; Schwanebeck, Uta ; Sisson, April ; Zerna, Charlotte ; Puetz, Volker ; Reichmann, Heinz ; Albright, Karen C. ; Alexandrov, Anne ; Vosko, Milan ; Mikulik, Robert ; Bodechtel, Ulf ; Alexandrov, Andrei. / 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. In: Trials. 2013 ; Vol. 14, No. 1.
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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.",
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T2 - Study protocol for a randomized controlled trial

AU - Kepplinger, Jessica

AU - Barlinn, Kristian

AU - Kolieskova, Stanislava

AU - Shahripour, Reza B.

AU - Pallesen, Lars Peder

AU - Schrempf, Wiebke

AU - Graehlert, Xina

AU - Schwanebeck, Uta

AU - Sisson, April

AU - Zerna, Charlotte

AU - Puetz, Volker

AU - Reichmann, Heinz

AU - Albright, Karen C.

AU - Alexandrov, Anne

AU - Vosko, Milan

AU - Mikulik, Robert

AU - Bodechtel, Ulf

AU - Alexandrov, Andrei

PY - 2013/8/13

Y1 - 2013/8/13

N2 - 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.

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