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
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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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