title: 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: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  This study has been registered at clinicaltrials.gov (NCT01363102).
authors: Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
authors: Matthew J
authors: MJ
authors: Meyer
authors: Anne B
authors: AB
authors: Stanislaus
authors: Jarone
authors: J
authors: Lee
authors: Karen
authors: K
authors: Waak
authors: Cheryl
authors: C
authors: Ryan
authors: Richa
authors: R
authors: Saxena
authors: Stephanie
authors: S
authors: Ball
authors: Ulrich
authors: U
authors: Schmidt
authors: Trudy
authors: T
authors: Poon
authors: Simone
authors: S
authors: Piva
authors: Matthias
authors: M
authors: Walz
authors: Daniel S
authors: DS
authors: Talmor
authors: Manfred
authors: M
authors: Blobner
authors: Nicola
authors: N
authors: Latronico
authors: Matthias
authors: M
authors: Eikermann
keywords: REHABILITATION MEDICINE; RESPIRATORY MEDICINE (see Thoracic Medicine)
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