Clinical Trial Unit, Swiss Paraplegic Center, Nottwil, Switzerland.
Life Course Epidemiology Group, Swiss Paraplegic Research, Nottwil, Switzerland.
BMJ Open. 2020 Nov 5;10(11):e038204. doi: 10.1136/bmjopen-2020-038204.
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.
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.
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.
ClinicalTrials.gov NCT02891096.
肺炎是脊髓损伤（SCI）后主要的并发症和死亡原因之一。颈或胸段损伤后，呼吸肌功能受损会降低呼吸功能，增加发生呼吸并发症的风险。肺炎会显著降低患者的生活质量，延长住院康复时间，增加医疗保健费用，甚至导致早逝。SCI 后可以通过各种干预措施来改善呼吸功能和咳嗽能力，但关于应优化哪些方面的呼吸护理的证据尚无定论。此外，呼吸功能参数预测肺炎风险的能力尚未得到充分证实。本文详细介绍了一项大规模、多中心研究项目的方案，该项目旨在评估呼吸功能参数预测和了解 SCI 住院患者肺炎风险变化的能力。
RESCOM 是一项前瞻性队列研究，于 2016 年 10 月在澳大利亚、奥地利、德国、荷兰和瑞士的 10 个 SCI 康复中心开始招募。符合纳入标准的患者为急性 SCI 住院患者，存在完全或不完全的颈或胸段损伤，年龄 18 岁或以上，且在损伤后 3 个月内无/不再依赖 24 小时机械通气。目标样本量为 500 名参与者。主要结局是发生肺炎；次要结局包括肺炎相关死亡率和生活质量。我们将使用纵向数据建立住院肺炎危险因素的预后模型。
该研究已在所有参与中心的所有当地伦理委员会进行了审查和批准。研究结果将通过同行评审期刊和会议演讲、SCI 社区、其他利益相关者以及通过社交媒体、时事通讯和参与活动向科学界传播。
ClinicalTrials.gov NCT02891096。
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