Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients

Abstract

IntroductionImmobilisation 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.Methods and analysisThe 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.Ethics and disseminationFollowing 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.ResultsThe 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.RegistrationThis study has been registered at clinicaltrials.gov (NCT01363102).

Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study

“…Muscle ultrasound is a valid and simple technique that could also be used for longitudinal assessment of treatment success. Future studies may use this technique to individualize postoperative interventions that may reduce the risk for an adverse discharge disposition related to critical illness, such as early mobilization, 49 optimized nutritional support, 50 and reduction of sedation and opioid dose.…”

Early mobilization in the critical care unit: A review of adult and pediatric literature

“…Surgical patients have unique considerations regarding mobilization including surgical wound pain, unstable fractures, open wounds, drains, and the patient's proximity to or from surgery [73]. A study of postsurgical, noncritical inpatients demonstrates that rehabilitation that incorporates ambulation starting day 1 postoperatively results in decreased LOS, fewer complications, and a faster recovery [74].…”

Understanding early goal-directed mobilization in the surgical intensive care unit

“…This aspect of the intervention likely helped address a lack of coordination among team members that is a commonly reported barrier to mobilization in the ICU (15). Moreover, the total physical therapy time was only modestly higher in the intervention vs. usual care group, with the SICU nurses actively involved in the mobilization activities (17).…”