Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries

Anja M Raab, Martin W G Brinkhof, David J Berlowitz, Karin Postma, David Gobets, Sven Hirschfeld, Maria T E Hopman, Burkhart Huber, Margret Hund-Georgiadis, Xavier Jordan, Martin Schubert, Renate Wildburger, Gabi Mueller, Anja M Raab, Martin W G Brinkhof, David J Berlowitz, Karin Postma, David Gobets, Sven Hirschfeld, Maria T E Hopman, Burkhart Huber, Margret Hund-Georgiadis, Xavier Jordan, Martin Schubert, Renate Wildburger, Gabi Mueller

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.

Keywords: epidemiology; rehabilitation medicine; respiratory infections.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Time frames for measurements (time-ponts: T1–T4) during inpatient rehabilitation. T1–T3 time-windows with days post injury (dpi) are shown by grey bars and T4 by the grey arrow above.
Figure 2
Figure 2
Global scheme of the planned data analysis investigating the dynamic association between respiratory function and pneumonia. In regression modelling, all variables will be time-updated in accordance with the repeated measurement schedule of RESpiratory COMplications and controlling for between-person and between-centre sources of variance. Respiratory function is operationalised using parameters of respiratory muscle strength and parameters of lung function.

References

    1. Schilero GJ, Radulovic M, Wecht JM, et al. . A center’s experience: pulmonary function in spinal cord injury. Lung 2014;192:339–46. 10.1007/s00408-014-9575-8
    1. Chamberlain JD, Buzzell A, Gmünder HP, et al. . Comparison of all-cause and cause-specific mortality of persons with traumatic spinal cord injuries to the general Swiss population: results from a national cohort study. Neuroepidemiology 2019;52:205–13. 10.1159/000496976
    1. Cardenas DD, Hoffman JM, Kirshblum S, et al. . Etiology and incidence of rehospitalization after traumatic spinal cord injury: a multicenter analysis. Arch Phys Med Rehabil 2004;85:1757–63. 10.1016/j.apmr.2004.03.016
    1. Dryden DM, Saunders LD, Rowe BH, et al. . Utilization of health services following spinal cord injury: a 6-year follow-up study. Spinal Cord 2004;42:513–25. 10.1038/sj.sc.3101629
    1. Aarabi B, Harrop JS, Tator CH, et al. . Predictors of pulmonary complications in blunt traumatic spinal cord injury. J Neurosurg Spine 2012;17:38–45. 10.3171/2012.4.AOSPINE1295
    1. Croce MA, Fabian TC, Waddle-Smith L, et al. . Identification of early predictors for post-traumatic pneumonia. Am Surg 2001;67:105–10.
    1. Postma K, Bussmann JB, Haisma JA, et al. . Predicting respiratory infection one year after inpatient rehabilitation with pulmonary function measured at discharge in persons with spinal cord injury. J Rehabil Med 2009;41:729–33. 10.2340/16501977-0410
    1. Agostinello J, Battistuzzo CR, Batchelor PE. Early clinical predictors of pneumonia in critically ill spinal cord injured individuals: a retrospective cohort study. Spinal Cord 2019;57:41–8. 10.1038/s41393-018-0196-6
    1. Jaja BNR, Jiang F, Badhiwala JH, et al. . Association of pneumonia, wound infection, and sepsis with clinical outcomes after acute traumatic spinal cord injury. J Neurotrauma 2019;36:3044–50. 10.1089/neu.2018.6245
    1. Berlowitz DJ, Tamplin J, Cochrane Injuries Group . Respiratory muscle training for cervical spinal cord injury. Cochrane Database Syst Rev 2013;72:CD008507 10.1002/14651858.CD008507.pub2
    1. Boswell-Ruys CL, Lewis CRH, Wijeysuriya NS, et al. . Impact of respiratory muscle training on respiratory muscle strength, respiratory function and quality of life in individuals with tetraplegia: a randomised clinical trial. Thorax 2020;75:279–88. 10.1136/thoraxjnl-2019-213917
    1. van Silfhout L, Peters AEJ, Berlowitz DJ, et al. . Long-Term change in respiratory function following spinal cord injury. Spinal Cord 2016;54:714–9. 10.1038/sc.2015.233
    1. Bican O, Minagar A, Pruitt AA. The spinal cord: a review of functional neuroanatomy. Neurol Clin 2013;31:1–18. 10.1016/j.ncl.2012.09.009
    1. Lanig IS, Peterson WP. The respiratory system in spinal cord injury. Phys Med Rehabil Clin N Am 2000;11:29–43. 10.1016/S1047-9651(18)30145-1
    1. Kang SW, Shin JC, Park CI, et al. . Relationship between inspiratory muscle strength and cough capacity in cervical spinal cord injured patients. Spinal Cord 2006;44:242–8. 10.1038/sj.sc.3101835
    1. Kang SW, Bach JR. Maximum insufflation capacity: vital capacity and cough flows in neuromuscular disease. Am J Phys Med Rehabil 2000;79:222–7. 10.1097/00002060-200005000-00002
    1. Park JH, Kang S-W, Lee SC, et al. . How respiratory muscle strength correlates with cough capacity in patients with respiratory muscle weakness. Yonsei Med J 2010;51:392–7. 10.3349/ymj.2010.51.3.392
    1. Postma K, Vlemmix LY, Haisma JA, et al. . Longitudinal association between respiratory muscle strength and cough capacity in persons with spinal cord injury: an explorative analysis of data from a randomized controlled trial. J Rehabil Med 2015;47:722–6. 10.2340/16501977-1986
    1. Kirshblum SC, Waring W, Biering-Sorensen F, et al. . Reference for the 2011 revision of the International standards for neurological classification of spinal cord injury. J Spinal Cord Med 2011;34:547–54. 10.1179/107902611X13186000420242
    1. Post MWM, Brinkhof MWG, von Elm E, et al. . Design of the Swiss spinal cord injury cohort study. Am J Phys Med Rehabil 2011;90:S5–16. 10.1097/PHM.0b013e318230fd41
    1. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control 2008;36:309–32. 10.1016/j.ajic.2008.03.002
    1. Biering-Sørensen F, Krassioukov A, Alexander MS, et al. . International spinal cord injury pulmonary function basic data set. Spinal Cord 2012;50:418–21. 10.1038/sc.2011.183
    1. Charlifue S, Post MW, Biering-Sørensen F, et al. . International spinal cord injury quality of life basic data set. Spinal Cord 2012;50:672–5. 10.1038/sc.2012.27
    1. American Thoracic Society Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 1995;152:1107–36.
    1. Miller MR, Hankinson J, Brusasco V, et al. . Standardisation of spirometry. Eur Respir J 2005;26:319–38. 10.1183/09031936.05.00034805
    1. American Thoracic Society/European Respiratory Society ATS/ERS statement on respiratory muscle testing. Am J Respir Crit Care Med 2002;166:518–624. 10.1164/rccm.166.4.518
    1. Wadsworth BM, Haines TP, Cornwell PL, et al. . Abdominal binder use in people with spinal cord injuries: a systematic review and meta-analysis. Spinal Cord 2009;47:274–85. 10.1038/sc.2008.126
    1. Hyppönen E, Berry DJ, Wjst M, et al. . Serum 25-hydroxyvitamin D and IgE - a significant but nonlinear relationship. Allergy 2009;64:613–20. 10.1111/j.1398-9995.2008.01865.x
    1. Verkuilen J. Explanatory item response models: a generalized linear and nonlinear approach by P. de Boeck and M. Wilson and generalized latent variable modeling: multilevel, longitudinal and structural equation models by A. Skrondal and S. Rabe-Hesketh. Psychometrika 2006;71:415–8. 10.1007/s11336-005-1333-7
    1. Steyerberg EW, Moons KGM, van der Windt DA, et al. . Prognosis research strategy (progress) 3: prognostic model research. PLoS Med 2013;10:e1001381. 10.1371/journal.pmed.1001381
    1. Altman DG, Vergouwe Y, Royston P, et al. . Prognosis and prognostic research: validating a prognostic model. BMJ 2009;338:b605. 10.1136/bmj.b605
    1. Biering-Sørensen F, Charlifue S, DeVivo M, et al. . International spinal cord injury data sets. Spinal Cord 2006;44:530–4. 10.1038/sj.sc.3101930
    1. Biering-Sørensen F, Charlifue S, Devivo MJ, et al. . Using the spinal cord injury common data elements. Top Spinal Cord Inj Rehabil 2012;18:23–7. 10.1310/sci1801-23

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir