Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients (mSOMS)

Tracking Information
First Submitted Date ICMJE	May 23, 2011
First Posted Date ICMJE	June 1, 2011
Last Update Posted Date	March 17, 2016
Study Start Date ICMJE	June 2011
Actual Primary Completion Date	July 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 31, 2011)	Average achieved SOMS level [ Time Frame: Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks). ]; Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01363102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 31, 2011)	SICU length of stay [ Time Frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks ]Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks.; The "mini" modified Functional Independence Measure (mmFIM) level [ Time Frame: mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively. ]Using the modified Functional Independence Measure (mmFIM), the levels of the locomotion and transfer mobility domain at hospital discharge (4 point NRS) will be compared between groups.; Quality of life following hospital discharge [ Time Frame: three months after hospital discharge ]SF 36 score; Muscle strength [ Time Frame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively. ]Medical Research Council (MRC) scale.; Side effects of mobilization therapy [ Time Frame: during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks. ]Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. AE were also categorized by intensity as mild, moderate, or severe; Genetic Polymorphisms as related to the other outcomes [ Time Frame: 5 minutes to collect sample ]Since Sleep duration has a genetic component corresponding to 40% heritability, we are going to conduct an analysis of known polymorphisms that are related to different variables of sleep quality and how it relates to muscle strength and mobility. In particular we will focus on polymorphisms in CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes, which are associated with sleepiness, sleep phase, inertia, and potentially with respiratory muscle weakness and duration.
Original Secondary Outcome Measures ICMJE; (submitted: May 31, 2011)	SICU length of stay [ Time Frame: days ]Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks.; The "mini" modified Functional Independence Measure (mmFIM) level [ Time Frame: mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively. ]Using the modified Functional Independence Measure (mmFIM), the levels of the locomotion and transfer mobility domain at hospital discharge (4 point NRS) will be compared between groups.; Quality of life following hospital discharge [ Time Frame: three months weeks after hospital discharge ]SF 36 score; Muscle strength [ Time Frame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively. ]Medical Research Council (MRC) scale.; Side effects of mobilization therapy [ Time Frame: during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks. ]Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. AE were also categorized by intensity as mild, moderate, or severe
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients
Official Title ICMJE	Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
Brief Summary	The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables.
Detailed Description	The trauma literature consistently shows that early mobilization improves patients' outcome after a localized trauma such as hip fracture, or blunt solid organ injuries. In addition, in critically ill patients on the medical ICU, early mobilization improves patients' functional outcome and decreases ICU length of stay (1). This study evaluates if critically ill patients in a surgical ICU can safely and effectively be mobilized early after trauma and surgery. The investigators propose to conduct a randomized controlled study in surgical intensive care unit patients to evaluate the effects of mSOMS guided early mobilization. Additionally, the study will examine known genetic polymorphisms as related to sleep quality and muscle strength and how it relates to early mobilization of surgical ICU patients. In particular, the study will focus on the following polymorphisms: CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Muscle Weakness; Critical Illness; Respiratory Insufficiency
Intervention ICMJE	Procedure: SOMS; Apply a number to mobilization goal for patient; Other Name: Early Mobilization
Study Arms	No Intervention: Control group Group will undergo usual mobilization per standard SICU care; Experimental: Study Group Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day. Intervention: Procedure: SOMS
Publications *	Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.; Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.; 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. 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. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 31, 2011)	200
Original Estimated Enrollment ICMJE; (submitted: May 31, 2011)	100
Estimated Study Completion Date	December 2016
Actual Primary Completion Date	July 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Adults (18 years of age or greater); Who have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hours; Who meet criteria for baseline functional independence (Barthel Index greater than or equal to 70 obtained from a proxy describing patient function 2 weeks before admission Exclusion Criteria: Irreversible disorders with 6-month mortality greater than 50%; Rapidly developing neuromuscular disease; Cardiopulmonary arrest; Motor component of Glascow Coma Scale <5; Elevated intracranial pressure; Ruptured/leaking aortic aneurysm; Acute MI before peak troponin has been reached; Absent lower limbs; Pregnancy; Unstable fractures contributing to likely immobility; Hospitalization prior to ICU admission >5 days; Enrollment in another clinical trial
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Austria, Germany, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01363102
Other Study ID Numbers ICMJE	11112010
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Matthias Eikermann, Massachusetts General Hospital
Study Sponsor ICMJE	Massachusetts General Hospital
Collaborators ICMJE	Beth Israel Deaconess Medical Center; University of Massachusetts, Worcester; Technische Universität München; University of Salzburg
Investigators ICMJE	Principal Investigator: Matthias Eikermann, MD, PhD The Massachusetts General Hospital
PRS Account	Massachusetts General Hospital
Verification Date	March 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP