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

Tracking Information

First Received Date ^ICMJE

May 23, 2011

Last Updated Date

March 16, 2016

Start Date ^ICMJE

June 2011

Primary Completion Date

July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01363102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

SICU length of stay [ Time Frame: days ]
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 weeks 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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Muscle Weakness
Critical Illness
Respiratory Insufficiency

Intervention ^ICMJE

Procedure: SOMS

Apply a number to mobilization goal for patient

Other Name: Early Mobilization

Study Arms

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2016

Primary Completion Date

July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria, Germany, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01363102

Other Study ID Numbers ^ICMJE

11112010

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Matthias Eikermann, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Technische Universität München
University of Salzburg

Investigators ^ICMJE

Principal Investigator:

Matthias Eikermann, MD, PhD

The Massachusetts General Hospital

PRS Account

Massachusetts General Hospital

Verification Date

March 2016

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

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