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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

Surgical ICU Optimal Mobilisation Score (SOMS) algorithm for goal-directed early mobilisation.
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BMJOPEN2013003262F2: Surgical ICU Optimal Mobilisation Score (SOMS) algorithm for goal-directed early mobilisation.

Mentions: The SOMS algorithm for goal-directed mobility ranges from ‘0—No mobility’ to ‘4—Ambulation’ (figure 2). The intermediate steps are ‘1—Passive Range of Motion,’ ‘2—Sitting,’ and ‘3—Standing.’ A SOMS of ‘0’ indicates that no mobilisation should be considered due to the clinical state of the participant. A SOMS of 1 indicates the nurse can perform passive range of motion exercises while the patient is in bed. The passive range of motion entails ankle dorsiflexion, knee and hip flexion, hip abduction, shoulder flexion, abduction and external rotation, wrist flexion and elbow flexion. The magnitude and frequency of passive range of motion is based on clinical discretion. A participant achieves a SOMS of 2 if able to sit either on the side of the bed or on a chair. A SOMS of 3 indicates that a patient is able to stand with or without assistance. The highest level a patient can achieve is a SOMS of 4, in which the patient is able to ambulate.


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)

Surgical ICU Optimal Mobilisation Score (SOMS) algorithm for goal-directed early mobilisation.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

BMJOPEN2013003262F2: Surgical ICU Optimal Mobilisation Score (SOMS) algorithm for goal-directed early mobilisation.
Mentions: The SOMS algorithm for goal-directed mobility ranges from ‘0—No mobility’ to ‘4—Ambulation’ (figure 2). The intermediate steps are ‘1—Passive Range of Motion,’ ‘2—Sitting,’ and ‘3—Standing.’ A SOMS of ‘0’ indicates that no mobilisation should be considered due to the clinical state of the participant. A SOMS of 1 indicates the nurse can perform passive range of motion exercises while the patient is in bed. The passive range of motion entails ankle dorsiflexion, knee and hip flexion, hip abduction, shoulder flexion, abduction and external rotation, wrist flexion and elbow flexion. The magnitude and frequency of passive range of motion is based on clinical discretion. A participant achieves a SOMS of 2 if able to sit either on the side of the bed or on a chair. A SOMS of 3 indicates that a patient is able to stand with or without assistance. The highest level a patient can achieve is a SOMS of 4, in which the patient is able to ambulate.

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