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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

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 Scor...

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Autores principales: Meyer, Matthew J, Stanislaus, Anne B, Lee, Jarone, Waak, Karen, Ryan, Cheryl, Saxena, Richa, Ball, Stephanie, Schmidt, Ulrich, Poon, Trudy, Piva, Simone, Walz, Matthias, Talmor, Daniel S, Blobner, Manfred, Latronico, Nicola, Eikermann, Matthias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753523/
https://www.ncbi.nlm.nih.gov/pubmed/23959756
http://dx.doi.org/10.1136/bmjopen-2013-003262
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author Meyer, Matthew J
Stanislaus, Anne B
Lee, Jarone
Waak, Karen
Ryan, Cheryl
Saxena, Richa
Ball, Stephanie
Schmidt, Ulrich
Poon, Trudy
Piva, Simone
Walz, Matthias
Talmor, Daniel S
Blobner, Manfred
Latronico, Nicola
Eikermann, Matthias
author_facet Meyer, Matthew J
Stanislaus, Anne B
Lee, Jarone
Waak, Karen
Ryan, Cheryl
Saxena, Richa
Ball, Stephanie
Schmidt, Ulrich
Poon, Trudy
Piva, Simone
Walz, Matthias
Talmor, Daniel S
Blobner, Manfred
Latronico, Nicola
Eikermann, Matthias
author_sort Meyer, Matthew J
collection PubMed
description 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).
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spelling pubmed-37535232013-08-28 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, Matthew J Stanislaus, Anne B Lee, Jarone Waak, Karen Ryan, Cheryl Saxena, Richa Ball, Stephanie Schmidt, Ulrich Poon, Trudy Piva, Simone Walz, Matthias Talmor, Daniel S Blobner, Manfred Latronico, Nicola Eikermann, Matthias BMJ Open Intensive Care 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). BMJ Publishing Group 2013-08-17 /pmc/articles/PMC3753523/ /pubmed/23959756 http://dx.doi.org/10.1136/bmjopen-2013-003262 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/
spellingShingle Intensive Care
Meyer, Matthew J
Stanislaus, Anne B
Lee, Jarone
Waak, Karen
Ryan, Cheryl
Saxena, Richa
Ball, Stephanie
Schmidt, Ulrich
Poon, Trudy
Piva, Simone
Walz, Matthias
Talmor, Daniel S
Blobner, Manfred
Latronico, Nicola
Eikermann, Matthias
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Intensive Care
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753523/
https://www.ncbi.nlm.nih.gov/pubmed/23959756
http://dx.doi.org/10.1136/bmjopen-2013-003262
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