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Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study

Background: We hypothesized that autotitrating bilevel positive airway pressure (auto-BPAP) favorably affects short-term clinical outcomes in hyperacute ischemic stroke. Methods: In a multicenter, randomized, controlled trial patients with large vessel steno-occlusive stroke and clinically suspected...

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Autores principales: Barlinn, Kristian, Jakubicek, Stanislava, Siepmann, Timo, Chernyshev, Oleg Y., Pallesen, Lars-Peder, Wienecke, Miriam, Hermann, Wiebke, Graehlert, Xina, Alexandrov, Anne W., Vosko, Milan, Puetz, Volker, Reichmann, Heinz, Bodechtel, Ulf, Mikulik, Robert, Barlinn, Jessica, Alexandrov, Andrei V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076592/
https://www.ncbi.nlm.nih.gov/pubmed/33927689
http://dx.doi.org/10.3389/fneur.2021.667494
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author Barlinn, Kristian
Jakubicek, Stanislava
Siepmann, Timo
Chernyshev, Oleg Y.
Pallesen, Lars-Peder
Wienecke, Miriam
Hermann, Wiebke
Graehlert, Xina
Alexandrov, Anne W.
Vosko, Milan
Puetz, Volker
Reichmann, Heinz
Bodechtel, Ulf
Mikulik, Robert
Barlinn, Jessica
Alexandrov, Andrei V.
author_facet Barlinn, Kristian
Jakubicek, Stanislava
Siepmann, Timo
Chernyshev, Oleg Y.
Pallesen, Lars-Peder
Wienecke, Miriam
Hermann, Wiebke
Graehlert, Xina
Alexandrov, Anne W.
Vosko, Milan
Puetz, Volker
Reichmann, Heinz
Bodechtel, Ulf
Mikulik, Robert
Barlinn, Jessica
Alexandrov, Andrei V.
author_sort Barlinn, Kristian
collection PubMed
description Background: We hypothesized that autotitrating bilevel positive airway pressure (auto-BPAP) favorably affects short-term clinical outcomes in hyperacute ischemic stroke. Methods: In a multicenter, randomized, controlled trial patients with large vessel steno-occlusive stroke and clinically suspected sleep apnea were allocated to auto-BPAP or standard stroke care alone. Auto-BPAP was initiated within 24 h from stroke onset and performed over 48 h during diurnal and nocturnal sleep. Sleep apnea was assessed using cardiorespiratory polygraphy. Primary endpoint was early neurological improvement on National Institutes of Health Stroke Scale (NIHSS) score at 72 h. Safety and tolerability of BPAP, functional independence [modified Rankin Scale (mRS) 0–2], stroke recurrence, and mortality at 90 days were assessed. Results: Due to low recruitment, the trial was prematurely stopped after 24 patients had been randomized (auto-BPAP, n = 14; control, n = 10): median baseline NIHSS 13 (5.5–18), 88% large vessel occlusion, and 12% large vessel stenosis. Polygraphy confirmed sleep apnea in 64% of auto-BPAP and 88% of control patients (p = 0.34). Adherence to auto-BPAP was achieved by 9 of the 14 (64%) patients. Between auto-BPAP and control patients, no differences were observed in early neurological improvement (median NIHSS change: −2.0, IQR = 7 points vs. −0.5, IQR = 3 points), 90 days functional independence (21 vs. 30%, p = 0.67), stroke recurrence (0 vs. 20%, p = 0.16), and death (14 vs. 20%, p = 1.0). No safety concerns were identified. Conclusions: In this prematurely terminated trial, auto-BPAP was safe but did not show an effect on short-term clinical outcomes in selected ischemic stroke patients. Its tolerability, however, may be limited in hyperacute stroke care and needs to be improved before larger trials are conducted. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT01812993.
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spelling pubmed-80765922021-04-28 Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study Barlinn, Kristian Jakubicek, Stanislava Siepmann, Timo Chernyshev, Oleg Y. Pallesen, Lars-Peder Wienecke, Miriam Hermann, Wiebke Graehlert, Xina Alexandrov, Anne W. Vosko, Milan Puetz, Volker Reichmann, Heinz Bodechtel, Ulf Mikulik, Robert Barlinn, Jessica Alexandrov, Andrei V. Front Neurol Neurology Background: We hypothesized that autotitrating bilevel positive airway pressure (auto-BPAP) favorably affects short-term clinical outcomes in hyperacute ischemic stroke. Methods: In a multicenter, randomized, controlled trial patients with large vessel steno-occlusive stroke and clinically suspected sleep apnea were allocated to auto-BPAP or standard stroke care alone. Auto-BPAP was initiated within 24 h from stroke onset and performed over 48 h during diurnal and nocturnal sleep. Sleep apnea was assessed using cardiorespiratory polygraphy. Primary endpoint was early neurological improvement on National Institutes of Health Stroke Scale (NIHSS) score at 72 h. Safety and tolerability of BPAP, functional independence [modified Rankin Scale (mRS) 0–2], stroke recurrence, and mortality at 90 days were assessed. Results: Due to low recruitment, the trial was prematurely stopped after 24 patients had been randomized (auto-BPAP, n = 14; control, n = 10): median baseline NIHSS 13 (5.5–18), 88% large vessel occlusion, and 12% large vessel stenosis. Polygraphy confirmed sleep apnea in 64% of auto-BPAP and 88% of control patients (p = 0.34). Adherence to auto-BPAP was achieved by 9 of the 14 (64%) patients. Between auto-BPAP and control patients, no differences were observed in early neurological improvement (median NIHSS change: −2.0, IQR = 7 points vs. −0.5, IQR = 3 points), 90 days functional independence (21 vs. 30%, p = 0.67), stroke recurrence (0 vs. 20%, p = 0.16), and death (14 vs. 20%, p = 1.0). No safety concerns were identified. Conclusions: In this prematurely terminated trial, auto-BPAP was safe but did not show an effect on short-term clinical outcomes in selected ischemic stroke patients. Its tolerability, however, may be limited in hyperacute stroke care and needs to be improved before larger trials are conducted. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT01812993. Frontiers Media S.A. 2021-04-13 /pmc/articles/PMC8076592/ /pubmed/33927689 http://dx.doi.org/10.3389/fneur.2021.667494 Text en Copyright © 2021 Barlinn, Jakubicek, Siepmann, Chernyshev, Pallesen, Wienecke, Hermann, Graehlert, Alexandrov, Vosko, Puetz, Reichmann, Bodechtel, Mikulik, Barlinn and Alexandrov. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Barlinn, Kristian
Jakubicek, Stanislava
Siepmann, Timo
Chernyshev, Oleg Y.
Pallesen, Lars-Peder
Wienecke, Miriam
Hermann, Wiebke
Graehlert, Xina
Alexandrov, Anne W.
Vosko, Milan
Puetz, Volker
Reichmann, Heinz
Bodechtel, Ulf
Mikulik, Robert
Barlinn, Jessica
Alexandrov, Andrei V.
Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study
title Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study
title_full Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study
title_fullStr Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study
title_full_unstemmed Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study
title_short Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study
title_sort autotitrating bilevel positive airway pressure in large vessel steno-occlusive stroke patients with suspected sleep apnea: a multicenter randomized controlled study
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076592/
https://www.ncbi.nlm.nih.gov/pubmed/33927689
http://dx.doi.org/10.3389/fneur.2021.667494
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