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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Muscle Weakness; Respiratory Insufficiency
• Intervention / Treatment: Procedure: SOMS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, A-5020
    • University of Salzburg
• Germany
  • Bavaria
    • München, Bavaria, Germany, D-81675
      • Technische Universität München
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • The Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Early Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average achieved SOMS level	Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.	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 Measures

Outcome Measure	Measure Description	Time Frame
SICU length of stay	Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks.	Patients will be followed until SICU discharge, an expected 2 days to 2 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.	mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively.
Quality of life following hospital discharge	SF 36 score	three months after hospital discharge
Muscle strength	Medical Research Council (MRC) scale.	ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.
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	during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.
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.	5 minutes to collect sample

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; University of Massachusetts, Worcester; Technical University of Munich; University of Salzburg
• Investigators: Principal Investigator: Matthias Eikermann, MD, PhD, The Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: May 31, 2011
• First Posted (Estimate): June 1, 2011

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 16, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: intensive care unit; quality of life; outcome; Muscle strength; functional mobility
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: 11112010