Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.
Immobilisation in the intensive care unit (ICU) leads to muscle weakness and is associated with increased costs and long-term functional disability. Previous studies showed early mobilisation of medical ICU patients improves clinical outcomes. The Surgical ICU Optimal Mobilisation Score (SOMS) trial aims to test whether a budget-neutral intervention to facilitate goal-directed early mobilisation in the surgical ICU improves participant mobilisation and associated clinical outcomes.
The SOMS trial is an international, multicentre, randomised clinical study being conducted in the USA and Europe. We are targeting 200 patients. The primary outcome is average daily SOMS level and key secondary outcomes are ICU length of stay until discharge readiness and 'mini' modified Functional Independence Measure (mmFIM) at hospital discharge. Additional secondary outcomes include quality of life assessed at 3 months after hospital discharge and global muscle strength at ICU discharge. Exploratory outcomes will include: ventilator-free days, ICU and hospital length of stay and 3-month mortality. We will explore genetic influences on the effectiveness of early mobilisation and centre-specific effects of early mobilisation on outcomes.
Following Institutional Review Board (IRB) approval in three institutions, we started study recruitment and plan to expand to additional centres in Germany and Italy. Safety monitoring will be the domain of the Data and Safety Monitoring Board (DSMB). The SOMS trial will also explore the feasibility of a transcontinental study on early mobilisation in the surgical ICU.
The results of this study, along with those of ancillary studies, will be made available in the form of manuscripts and presentations at national and international meetings.
This study has been registered at clinicaltrials.gov (NCT01363102).
重症监护病房（ICU）中的固定会导致肌肉无力，并与增加成本和长期功能障碍相关。先前的研究表明，早期移动 ICU 中的医疗患者可以改善临床结果。外科 ICU 最佳移动评分（SOMS）试验旨在测试在外科 ICU 中促进目标导向早期移动的预算中性干预是否可以改善参与者的移动能力和相关临床结果。
SOMS 试验是一项国际性的、多中心的随机临床试验，正在美国和欧洲进行。我们的目标是 200 名患者。主要结果是平均每日 SOMS 水平，关键次要结果是 ICU 住院时间直到出院准备就绪以及出院时的“迷你”改良功能独立性测量（mmFIM）。其他次要结果包括出院后 3 个月的生活质量评估和 ICU 出院时的整体肌肉力量。探索性结果将包括：无呼吸机天数、ICU 和医院住院时间以及 3 个月死亡率。我们将探索早期移动的有效性的遗传影响以及早期移动对结果的特定中心影响。
在三个机构获得机构审查委员会（IRB）批准后，我们开始了研究招募，并计划在德国和意大利的其他中心扩展。安全监测将是数据和安全监测委员会（DSMB）的领域。SOMS 试验还将探索在外科 ICU 中进行跨大陆早期移动研究的可行性。
这项研究的结果，以及辅助研究的结果，将以手稿和演示文稿的形式在国家和国际会议上公布。
本研究已在 clinicaltrials.gov（NCT01363102）注册。
