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Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries
  1. Anja M Raab1,
  2. Martin W G Brinkhof2,
  3. David J Berlowitz3,4,
  4. Karin Postma5,
  5. David Gobets6,
  6. Sven Hirschfeld7,
  7. Maria T E Hopman8,
  8. Burkhart Huber9,
  9. Margret Hund-Georgiadis10,
  10. Xavier Jordan11,
  11. Martin Schubert12,
  12. Renate Wildburger13,
  13. Gabi Mueller1
  1. 1Clinical Trial Unit, Swiss Paraplegic Center, Nottwil, Switzerland
  2. 2Life Course Epidemiology Group, Swiss Paraplegic Research, Nottwil, Switzerland
  3. 3Department of Respiratory and Sleep Medicine, Institute for Breathing and Sleep, Heidelberg, Victoria, Australia
  4. 4Department of Physiotherapy, University of Melbourne, Melbourne, Victoria, Australia
  5. 5Department of Rehabilitation Medicine, Rijndam Rehabilitation and Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
  6. 6Department of Rehabilitation Medicine, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands
  7. 7Department of Spinal Cord Medicine, BG Trauma Hospital, Hamburg, Germany
  8. 8Center for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
  9. 9Trauma Surgery, AUVA Rehabilitation Center Häring, Bad Häring, Austria
  10. 10Clinic for neurorehabilitation and paraplegiology, REHAB Basel, Basel, Switzerland
  11. 11Spinal Cord Unit, Clinique romande de réadaptation, Sion, Switzerland
  12. 12Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland
  13. 13Allgemeine Unfallversicherungsanstalt, AUVA Rehabilitation Clinic Tobelbad, Tobelbad, Austria
  1. Correspondence to Dr Gabi Mueller; gabi.mueller{at}paraplegie.ch

Abstract

Introduction Pneumonia is one of the leading complications and causes of death after a spinal cord injury (SCI). After a cervical or thoracic lesion, impairment of the respiratory muscles decreases respiratory function, which increases the risk of respiratory complications. Pneumonia substantially reduces patient’s quality of life, may prolong inpatient rehabilitation time, increase healthcare costs or at worse, lead to early death. Respiratory function and coughing can be improved through various interventions after SCI, but the available evidence as to which aspect of respiratory care should be optimised is inconclusive. Furthermore, ability of respiratory function parameters to predict pneumonia risk is insufficiently established. This paper details the protocol for a large-scale, multicentre research project that aims to evaluate the ability of parameters of respiratory function to predict and understand variation in inpatient risk of pneumonia in SCI.

Methods and analysis RESCOM, a prospective cohort study, began recruitment in October 2016 across 10 SCI rehabilitation centres from Australia, Austria, Germany, the Netherlands and Switzerland. Inpatients with acute SCI, with complete or incomplete cervical or thoracic lesions, 18 years or older and not/no more dependent on 24-hour mechanical ventilation within the first 3 months after injury are eligible for inclusion. The target sample size is 500 participants. The primary outcome is an occurrence of pneumonia; secondary outcomes include pneumonia-related mortality and quality of life. We will use the longitudinal data for prognostic models on inpatient pneumonia risk factors.

Ethics and dissemination The study has been reviewed and approved by all local ethics committees of all participating centres. Study results will be disseminated to the scientific community through peer-reviewed journals and conference presentations, to the SCI community, other stakeholders and via social media, newsletters and engagement activities.

Trial registration details ClinicalTrials.gov NCT02891096.

  • respiratory infections
  • rehabilitation medicine
  • epidemiology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @derdevid

  • AMR and MWGB contributed equally.

  • Contributors GM is the principal investigator of the RESpiratory COMplications project. AMR and GM designed the study. MWGB provided statistical and methodological support. DJB, KP, DG, SH, MTEH, BH, MH-G, XJ, MS and RW provided clinical support and/or are responsible for data collection in their respective clinics. AMR, MWGB and GM drafted the work and DJB, KP, DG, SH, MTEH, BH, MH-G, XJ, MS and RW revised it critically for important intellectual content. AMR was responsible for the monitoring visits. All authors approved the final version of the manuscript and agreed to be accountable for all aspects of the work.

  • Funding This project is supported by Wings for Life, a spinal cord research foundation (Salzburg, Austria), grant number WFL-CH-014/16. Start-up costs for the participating Swiss Centres were covered by the SwiSCI nested project start-up grant of the Swiss Paraplegic Foundation.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Ethics approval Approved by all local ethics committees of all participating centers, namely: for Switzerland: ethics committee north-west and central Switzerland (EKNZ) for the two Swiss Centres SPZ Nottwil and REHAB Basel, ethics committee Zurich, Switzerland for the Balgrist, Zurich and Ethics Committee Vaud, Switzerland for the CRR Sion (Nr. 2016-01065 – one multi-centric application for all Swiss centres). In Germany from the ‘Ethikkommission der Ärztekammer Hamburg’ (Nr. PV 5502); for Austria from the ‘Ethikkommission der Medizinischen Universität Innsbruck’ (Nr. AN-2016-0176) and the ‘Ethikkommission für die Krankenanstalten der AUVA’ (Nr. 6/2016). In the Netherlands from the medical ethics committee of the Erasmus Medical Centre Rotterdam (Nr. MEC-2016-594) and for Autralia from the Austin Health Human Research Ethics Committee (Nr. LNR/16/Austin/422).

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

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