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Randomised controlled trial of polysomnographic titration of noninvasive ventilation

Liam M. Hannan, Linda Rautela, David J. Berlowitz, Christine F. McDonald, Jennifer M. Cori, Nicole Sheers, Caroline Chao, Fergal J. O'Donoghue, Mark E. Howard
European Respiratory Journal 2019 53: 1802118; DOI: 10.1183/13993003.02118-2018
Liam M. Hannan
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
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Linda Rautela
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Physiotherapy, University of Melbourne, Melbourne, Australia
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David J. Berlowitz
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Physiotherapy, University of Melbourne, Melbourne, Australia
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Christine F. McDonald
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
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Jennifer M. Cori
Institute for Breathing and Sleep, Austin Health, Melbourne, Australia
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Nicole Sheers
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Physiotherapy, University of Melbourne, Melbourne, Australia
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Caroline Chao
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Physiotherapy, University of Melbourne, Melbourne, Australia
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Fergal J. O'Donoghue
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
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Mark E. Howard
Institute for Breathing and Sleep, Austin Health, Melbourne, AustraliaDept of Respiratory and Sleep Medicine, Austin Health, Melbourne, AustraliaDept of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
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Abstract

Noninvasive ventilation (NIV) settings determined during wakefulness may produce patient–ventilator asynchrony (PVA) during sleep, causing sleep disruption and limiting tolerance. This study investigated whether NIV titrated with polysomnography (PSG) is associated with less PVA and sleep disruption than therapy titrated during daytime alone.

Treatment-naive individuals referred for NIV were randomised to control (daytime titration followed by sham polysomnographic titration) or PSG (daytime titration followed by polysomnographic titration) groups. Primary outcomes were PVA and arousal indices on PSG at 10 weeks. Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).

In total, 60 participants were randomised. Most (88.3%) had a neuromuscular disorder and respiratory muscle weakness but minor derangements in daytime arterial blood gases. PVA events were less frequent in those undergoing polysomnographic titration (median (interquartile range (IQR)): PSG 25.7 (12–68) events·h−1 versus control 41.0 (28–182) events·h−1; p=0.046), but arousals were not significantly different (median (IQR): PSG 11.4 (9–19) arousals·h−1 versus control 14.6 (11–19) arousals·h−1; p=0.258). Overall adherence was not different except in those with poor early adherence (<4 h·day−1) who increased their use after polysomnographic titration (mean difference: PSG 95 (95% CI 29–161) min·day−1 versus control −23 (95% CI −86–39) min·day−1; p=0.01). Arterial carbon dioxide tension, somnolence and sleep quality improved in both groups. There were no differences in nocturnal gas exchange or overall measures of HRQoL.

NIV titrated with PSG is associated with less PVA but not less sleep disruption when compared with therapy titrated during daytime alone.

Abstract

In a cohort comprised mostly of individuals with neuromuscular disorders, nocturnal noninvasive ventilation was associated with less patient–ventilator asynchrony and adherence was better when treatment was titrated during polysomnography http://ow.ly/xibR30nY8c7

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • This study was registered prospectively with the Australian New Zealand Clinical Trials Registry with identifier number 365405. Individual participant data that underlie the results reported in this article will be available for sharing after de-identification (text, tables, figures and appendices). The study protocol will also be available. These data will be available beginning 12 months and ending 36 months following article publication to researchers who provide a methodologically sound proposal and with approval of the Research Ethics Board who originally approved the study. Proposals should be directed to liam.hannan{at}austin.org.au. To gain access, data requestors will need to sign a data access agreement.

  • Author contributions: L.M. Hannan was responsible for the study conception, design, data collection, analysis, coordination and preparation of the manuscript. L. Rautela, N. Sheers and C. Chao assisted with study design, data collection and analysis. J.M. Cori assisted with preparation of the manuscript. D.J. Berlowitz, C.F. McDonald, F.J. O'Donoghue and M.E. Howard assisted with study conception, design, analysis and preparation of the manuscript.

  • Conflict of interest: L.M. Hannan received a postgraduate scholarship grant from the National Health and Medical Research Council (Australia), during the conduct of the study.

  • Conflict of interest: L. Rautela has nothing to disclose.

  • Conflict of interest: D.J. Berlowitz has nothing to disclose.

  • Conflict of interest: C.F. McDonald has nothing to disclose.

  • Conflict of interest: J.M. Cori has nothing to disclose.

  • Conflict of interest: N. Sheers has nothing to disclose.

  • Conflict of interest: C. Chao has nothing to disclose.

  • Conflict of interest: F.J. O'Donoghue has nothing to disclose.

  • Conflict of interest: M.E. Howard has nothing to disclose.

  • Support statement: This study was supported by research grants from the Institute for Breathing and Sleep and the Austin Medical Research Foundation. L.M. Hannan received financial support during this project in the form of a postgraduate scholarship from the National Health and Medical Research Foundation (Australia).

  • Received November 6, 2018.
  • Accepted March 3, 2019.
  • Copyright ©ERS 2019
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Randomised controlled trial of polysomnographic titration of noninvasive ventilation
Liam M. Hannan, Linda Rautela, David J. Berlowitz, Christine F. McDonald, Jennifer M. Cori, Nicole Sheers, Caroline Chao, Fergal J. O'Donoghue, Mark E. Howard
European Respiratory Journal May 2019, 53 (5) 1802118; DOI: 10.1183/13993003.02118-2018

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Randomised controlled trial of polysomnographic titration of noninvasive ventilation
Liam M. Hannan, Linda Rautela, David J. Berlowitz, Christine F. McDonald, Jennifer M. Cori, Nicole Sheers, Caroline Chao, Fergal J. O'Donoghue, Mark E. Howard
European Respiratory Journal May 2019, 53 (5) 1802118; DOI: 10.1183/13993003.02118-2018
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