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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.

Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M - BMJ Open (2013)

Bottom Line: Exploratory outcomes will include: ventilator-free days, ICU and hospital length of stay and 3-month mortality.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).

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.

ABSTRACT

Introduction: 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 and analysis: 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.

Ethics and dissemination: 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.

Registration: This study has been registered at clinicaltrials.gov (NCT01363102).

No MeSH data available.


Related in: MedlinePlus

Participant progression through the study protocol. GCS, Glasgow Coma Scale; ICU, intensive care unit; LOS, length of stay; mmFIM, ‘mini’ modified Functional Independence Measure; MRC, Medical Research Council; SOMS, Surgical ICU Optimal Mobilisation Score.
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BMJOPEN2013003262F1: Participant progression through the study protocol. GCS, Glasgow Coma Scale; ICU, intensive care unit; LOS, length of stay; mmFIM, ‘mini’ modified Functional Independence Measure; MRC, Medical Research Council; SOMS, Surgical ICU Optimal Mobilisation Score.

Mentions: The SOMS group has designed an international, multicentre, randomised controlled trial. An outline of the study design and daily work is provided in figure 1. We pledge to adhere to the CONSORT 2010 Statement26 for reporting of our trial.


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.

Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M - BMJ Open (2013)

Participant progression through the study protocol. GCS, Glasgow Coma Scale; ICU, intensive care unit; LOS, length of stay; mmFIM, ‘mini’ modified Functional Independence Measure; MRC, Medical Research Council; SOMS, Surgical ICU Optimal Mobilisation Score.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3753523&req=5

BMJOPEN2013003262F1: Participant progression through the study protocol. GCS, Glasgow Coma Scale; ICU, intensive care unit; LOS, length of stay; mmFIM, ‘mini’ modified Functional Independence Measure; MRC, Medical Research Council; SOMS, Surgical ICU Optimal Mobilisation Score.
Mentions: The SOMS group has designed an international, multicentre, randomised controlled trial. An outline of the study design and daily work is provided in figure 1. We pledge to adhere to the CONSORT 2010 Statement26 for reporting of our trial.

Bottom Line: Exploratory outcomes will include: ventilator-free days, ICU and hospital length of stay and 3-month mortality.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).

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.

ABSTRACT

Introduction: 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 and analysis: 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.

Ethics and dissemination: 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.

Registration: This study has been registered at clinicaltrials.gov (NCT01363102).

No MeSH data available.


Related in: MedlinePlus