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.
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
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.


CONCLUSIONS
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.


BACKGROUND
Clinicaltrials.gov Identifier: NCT01812993.
Jessica
J
Kepplinger
Kristian
K
Barlinn
Stanislava
S
Kolieskova
Reza Bavarsad
RB
Shahripour
Lars-Peder
LP
Pallesen
Wiebke
W
Schrempf
Xina
X
Graehlert
Uta
U
Schwanebeck
April
A
Sisson
Charlotte
C
Zerna
Volker
V
Puetz
Heinz
H
Reichmann
Karen C
KC
Albright
Anne W
AW
Alexandrov
Milan
M
Vosko
Robert
R
Mikulik
Ulf
U
Bodechtel
Andrei V
AV
Alexandrov
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D012119:Respiration; D012890:Sleep; D012891:Sleep Apnea Syndromes / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D020521:Stroke / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult