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

Primary Purpose

Muscle Weakness, Critical Illness, Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SOMS
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Muscle strength, functional mobility, outcome, intensive care unit, quality of life

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts
  • University of Salzburg
  • Technische Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Study Group

Arm Description

Group will undergo usual mobilization per standard SICU care

Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day.

Outcomes

Primary Outcome Measures

Average achieved SOMS level
Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.

Secondary Outcome Measures

SICU length of stay
Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks.
The "mini" modified Functional Independence Measure (mmFIM) level
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
SF 36 score
Muscle strength
Medical Research Council (MRC) scale.
Side effects of mobilization therapy
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
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.

Full Information

First Posted
May 23, 2011
Last Updated
March 16, 2016
Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center, University of Massachusetts, Worcester, Technical University of Munich, University of Salzburg
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1. Study Identification

Unique Protocol Identification Number
NCT01363102
Brief Title
Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients
Acronym
mSOMS
Official Title
Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center, University of Massachusetts, Worcester, Technical University of Munich, University of Salzburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Critical Illness, Respiratory Insufficiency
Keywords
Muscle strength, functional mobility, outcome, intensive care unit, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group will undergo usual mobilization per standard SICU care
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day.
Intervention Type
Procedure
Intervention Name(s)
SOMS
Other Intervention Name(s)
Early Mobilization
Intervention Description
Apply a number to mobilization goal for patient
Primary Outcome Measure Information:
Title
Average achieved SOMS level
Description
Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.
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).
Secondary Outcome Measure Information:
Title
SICU length of stay
Description
Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks.
Time Frame
Patients will be followed until SICU discharge, an expected 2 days to 2 weeks
Title
The "mini" modified Functional Independence Measure (mmFIM) level
Description
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.
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.
Title
Quality of life following hospital discharge
Description
SF 36 score
Time Frame
three months after hospital discharge
Title
Muscle strength
Description
Medical Research Council (MRC) scale.
Time Frame
ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.
Title
Side effects of mobilization therapy
Description
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
Time Frame
during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.
Title
Genetic Polymorphisms as related to the other outcomes
Description
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.
Time Frame
5 minutes to collect sample

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Eikermann, MD, PhD
Organizational Affiliation
The Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Salzburg
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Technische Universität München
City
München
State/Province
Bavaria
ZIP/Postal Code
D-81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22067629
Citation
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.
Results Reference
background
PubMed Identifier
27707496
Citation
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.
Results Reference
derived
PubMed Identifier
23959756
Citation
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.
Results Reference
derived

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

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