Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients (mSOMS)
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|ClinicalTrials.gov Identifier: NCT01363102|
Recruitment Status : Unknown
Verified March 2016 by Matthias Eikermann, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 1, 2011
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Muscle Weakness Critical Illness Respiratory Insufficiency||Procedure: SOMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2016|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363102
|United States, Massachusetts|
|The Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|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|