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Polysomnography versus limited respiratory monitoring and nurse-led titration to optimise non-invasive ventilation set-up: a pilot randomised clinical trial
  1. Maxime Patout1,2,3,
  2. Gill Arbane1,3,
  3. Antoine Cuvelier2,
  4. Jean Francois Muir2,
  5. Nicholas Hart1,3,4,
  6. Patrick Brian Murphy1,3,4
  1. 1Lane Fox Respiratory Unit, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  2. 2Normandie Univ, UNIRouen, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), Rouen University Hospital, Service de Pneumologie, Oncologie thoracique et Soins Intensifs Respiratoires, Rouen, France
  3. 3Lane Fox Clinical Respiratory Physiology Research Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  4. 4Centre for Human, Aerospace and Physiological Sciences, King’s College London, London, UK
  1. Correspondence to Dr Maxime Patout, Lane Fox Respiratory Unit, St-Thomas Hospital, London SE1 7EH, UK; maxime.patout{at}chu-rouen.fr

Abstract

Polysomnography (PSG) is recommended for non-invasive ventilation (NIV) set-up in patients with chronic respiratory failure. In this pilot randomised clinical trial, we compared the physiological effectiveness of NIV set-up guided by PSG to limited respiratory monitoring (LRM) and nurse-led titration in patients with COPD–obstructive sleep apnoea (OSA) overlap. The principal outcome of interest was change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months. Fourteen patients with daytime PaCO2 >6 kPa and body mass index >30 kg/m2 were recruited. At 3 months, PaCO2 was reduced by −0.88 kPa (95% CI −1.52 to −0.24 kPa) in the LRM group and by −0.36 kPa (95% CI −0.96 to 0.24 kPa) in the PSG group. These pilot data provide support to undertake a clinical trial investigating the clinical effectiveness of attended limited respiratory monitoring and PSG to establish NIV in patients with COPD–OSA overlap.

Trial number Results, NCT02444806.

  • non invasive ventilation
  • sleep apnoea

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Footnotes

  • Contributors MP: conception of the work, acquisition, analysis, interpretation of data, drafting of the work. GA: acquisition of data, critical revising of the draft. AC, JFM, NH: conception of the work, critical revising of the draft. PBM: conception of the work, acquisition, analysis, interpretation of data, drafting and critical revising of the draft.

  • Funding MP received a research grant from ADIR association (grant no. ADIR-2014-01).

  • Competing interests MP reports grants from ADIR Association, from B&D Electromedical, during the conduct of the study; personal fees from Fisher & Paykel and ResMed, non-financial support from Antadir and Asten, outside the submitted work. JFM reports grants from ADIR Association, during the conduct of the study; personal fees from Philips-Respironics, personal fees from ResMed, personal fees from Air Liquide Santé, personal fees from Breas, personal fees from Boehringer, outside the submitted work. NH reports grants from Guy’s and St Thomas’ Charity, during the conduct of the study; grants from Philips-Respironics, non-financial support from Philips-Respironics RT Meeting (MYOTRACE), personal fees from Fisher & Paykel, grants from ResMed, grants from B&D Electromedical, grants from Fisher & Paykel, outside the submitted work. In addition, NH has a patent MYOTRACE pending and MP is on the Pulmonary Research Advisory Board for Philips. NH’s research group has received unrestricted grants (managed by Guy’s and St Thomas’ Foundation Trust) from Philips-Respironics, Philips, ResMed, Fisher & Paykel, and B&D Electromedical. Philips-Respironics are contributing to the development of the MYOTRACE technology. PBM reports grants and personal fees from Philips-Respironics, grants from ResMed, grants from B&D Electromedical, outside the submitted work. Other authors have no competing interests to declare.

  • Patient consent Obtained.

  • Ethics approval Guy’s Research Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Author note MP is the guarantor of the content of the manuscript, including the data and analysis.

  • Correction notice This article has been corrected since it was published Online First. A sentence in the Abstract and the Outcome section has been corrected.

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