Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients (mSOMS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients|
- 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). ] [ Designated as safety issue: No ]Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.
- SICU length of stay [ Time Frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]SF 36 score
- Muscle strength [ Time Frame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||November 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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.
Apply a number to mobilization goal for patient
Other Name: Early Mobilization
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363102
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|The Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|University of Massachusetts|
|Worcester, Massachusetts, United States, 01605|
|University of Salzburg|
|Salzburg, Austria, A-5020|
|Technische Universität München|
|München, Bavaria, Germany, D-81675|
|Principal Investigator:||Matthias Eikermann, MD, PhD||The Massachusetts General Hospital|