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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Muscle Weakness Critical Illness Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Group will undergo usual mobilization per standard SICU care

Group Type NO_INTERVENTION

No interventions assigned to this group

Study Group

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

Group Type EXPERIMENTAL

SOMS

Intervention Type PROCEDURE

Apply a number to mobilization goal for patient

Interventions

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SOMS

Apply a number to mobilization goal for patient

Intervention Type PROCEDURE

Other Intervention Names

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Early Mobilization

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No