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

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Mass General Brigham

Status

Unknown

Conditions

Respiratory Insufficiency
Critical Illness
Muscle Weakness

Treatments

Procedure: SOMS

Study type

Interventional

Funder types

Other

Identifiers

NCT01363102
11112010

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Control group
No Intervention group
Description:
Group will undergo usual mobilization per standard SICU care
Study Group
Experimental group
Description:
Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day.
Treatment:
Procedure: SOMS

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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