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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Technische Universität München
University of Salzburg
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01363102
First received: May 23, 2011
Last updated: March 16, 2016
Last verified: March 2016
History of Changes

May 23, 2011
March 16, 2016
June 2011
July 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01363102 on ClinicalTrials.gov Archive Site
  • 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.
  • SICU length of stay [ Time Frame: days ] [ 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 weeks 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
Not Provided
Not Provided
 
Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients
Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Muscle Weakness
  • Critical Illness
  • Respiratory Insufficiency
Procedure: SOMS
Apply a number to mobilization goal for patient
Other Name: Early Mobilization
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2016
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Germany
 
NCT01363102
11112010
Yes
Not Provided
Not Provided
Matthias Eikermann, Massachusetts General Hospital
Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts, Worcester
  • Technische Universität München
  • University of Salzburg
Principal Investigator: Matthias Eikermann, MD, PhD The Massachusetts General Hospital
Massachusetts General Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP