Clinical trial NCT01769846: The Impact of Early Mobilization Protocol in Patients in the ICU
Official title: The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Quality of Life
Weaning Acceleration
ICU Length of Stay
Muscle Thickness of the Quadriceps Femoris
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Enrollment in another clinical trial

Primary outcomes:
measure: Muscle thickness (MT) of the quadriceps femoris.
timeFrame: Change from baseline at 14 day of ICU admission, an average of 1 month.
measure: Muscle thickness (MT) of the diaphragm.
timeFrame: Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary outcomes:
measure: Rectus femoris cross-sectional area
timeFrame: Change from baseline at 14 day of ICU admission, an average of 1 month.
measure: Vastus intermedius, rectus femoris and diaphragm echo intensity.
timeFrame: Change from baseline at 14 day of ICU admission, an average of 1 month.
measure: Rectus femoris and vastus intermedius thickness.
timeFrame: Change from baseline at 14 day of ICU admission, an average of 1 month.
measure: Muscle strength
timeFrame: First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.
measure: Gait speed
timeFrame: Study completion, an average of 2 months (hospital discharge)
measure: Peripheral muscle strength of the lower limbs
timeFrame: Study completion, an average of 2 months (hospital discharge)
measure: Quality of life following hospital discharge
timeFrame: Three months after hospital discharge SF36
measure: Mortality
timeFrame: Patients will be followed until three months after hospital discharge
measure: ICU length of stay
timeFrame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.
measure: Weaning Acceleration
timeFrame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks
measure: Side effects of mobilization protocol
timeFrame: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.
measure: Length of hospital stay
timeFrame: Patients will be followed until hospital discharge, an expected 4 to 6 weeks
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: University Hospital of Santa Maria
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Isabella Albuquerque, DSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machado ADS, Pires-Neto RC, Carvalho MTX, Soares JC, Cardoso DM, Albuquerque IM. Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol. 2017 Mar-Apr;43(2):134-139. doi: 10.1590/S1806-37562016000000170.