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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Massachusetts General Hospital
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01363102
First received: May 23, 2011
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Muscle Weakness
Critical Illness
Respiratory Insufficiency
Procedure: SOMS

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: SOMS
Apply a number to mobilization goal for patient
Other Name: Early Mobilization

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363102

Contacts
Contact: Matthias Eikermann, MD, PhD 617-643-4408 meikermann@partners.org
Contact: Jessica Hines 6177262859 jhines1@partners.org

Locations
United States, Massachusetts
The Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Matthew Meyer, MD       mjmeyer@partners.org   
Principal Investigator: Matthias Eikermann, MD, PhD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthias Anstey, MD       manstey@bidmc.harvard.edu   
Principal Investigator: Daniel Talmor, MD, MPH         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Matthias Walz, MD       Matthias.Walz@umassmemorial.org   
Principal Investigator: Matthias Walz, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD The Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Matthias Eikermann, Director of Research, Surgical Intensive Care Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01363102     History of Changes
Other Study ID Numbers: 11112010
Study First Received: May 23, 2011
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Muscle strength
functional mobility
outcome
intensive care unit
quality of life

Additional relevant MeSH terms:
Asthenia
Critical Illness
Muscle Weakness
Paresis
Respiratory Insufficiency
Signs and Symptoms
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014