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



Status:Active, not recruiting
Conditions:Cardiology, Hospital, Neurology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - 85
Updated:11/1/2017
Start Date:June 2011
End Date:December 2016

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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.

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
We found this trial at
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Worcester, Massachusetts 01655
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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7 Jakob-Haringer-Straße
Salzburg, 5020
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Salzburg,
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