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Clinical Trials/NCT01769846
NCT01769846
Completed
Not Applicable

The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.

Universidade Federal de Santa Maria1 site in 1 country28 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Weakness
Sponsor
Universidade Federal de Santa Maria
Enrollment
28
Locations
1
Primary Endpoint
Muscle thickness (MT) of the quadriceps femoris.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient.

The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
August 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isabella Martins de Albuquerque

Professor DSc.

Universidade Federal de Santa Maria

Eligibility Criteria

Inclusion Criteria

  • Adults (18 years of age or greater)
  • Patients in the first 24 hours of mechanical ventilation.
  • Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).
  • Hemodynamically stable.

Exclusion Criteria

  • Rapidly developing neuromuscular disease
  • Evolution of brain death
  • Cardiopulmonary arrest
  • Elevated intracranial pressure
  • Ruptured/leaking aortic aneurysm
  • Acute MI before peak troponin has been reached
  • Absent lower limb
  • Pregnancy
  • Unstable fractures contributing to likely immobility
  • Hospitalization prior to ICU admission \>5 days

Outcomes

Primary Outcomes

Muscle thickness (MT) of the quadriceps femoris.

Time Frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).

Muscle thickness (MT) of the diaphragm.

Time Frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).

Secondary Outcomes

  • Gait speed(Study completion, an average of 2 months (hospital discharge))
  • Quality of life following hospital discharge(Three months after hospital discharge SF36)
  • Mortality(Patients will be followed until three months after hospital discharge)
  • Length of hospital stay(Patients will be followed until hospital discharge, an expected 4 to 6 weeks)
  • Rectus femoris cross-sectional area(Change from baseline at 14 day of ICU admission, an average of 1 month.)
  • Rectus femoris and vastus intermedius thickness.(Change from baseline at 14 day of ICU admission, an average of 1 month.)
  • Peripheral muscle strength of the lower limbs(Study completion, an average of 2 months (hospital discharge))
  • Vastus intermedius, rectus femoris and diaphragm echo intensity.(Change from baseline at 14 day of ICU admission, an average of 1 month.)
  • Muscle strength(First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.)
  • ICU length of stay(Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.)
  • Weaning Acceleration(Patients will be followed until ICU discharge, an expected 2 days to 3 weeks)
  • Side effects of mobilization protocol(During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.)

Study Sites (1)

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