The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Muscle thickness (MT) of the quadriceps femoris.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Early Mobilization protocol
Early Mobilization protocol: Patients in the treatment group additionally received a progressive cycling exercise session 7 days a week, until the last day of ICU stay, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH & Co. KG, Betzenweiler, Germany). Cycling exercise will be realized during 30 consecutive minutes, initially in continuos and passive (classified patients with RASS - 4) exercise, at a fixed pedaling rate of 20 cycles/min and after in actively (classified patients with RASS 0), with an exercise intensity of 3-5 on the Borg rate of perceived exertion scale.
Intervention: Early mobilization protocol (Other)
Control group
Group will undergo usual mobilization per standard ICU care. Conventional physical and respiratory therapy were provided by the ICU physical therapists twice daily, for approximately 30 min, 7 days per week. The protocol included vibrocompression maneuvers; lung hyperinflation by the mechanical ventilator; and tracheal aspiration, when necessary; as well as passive and active-assisted motor exercises for arms and legs, depending on the clinical course of patients.
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
- Weaning Acceleration(Patients will be followed until ICU discharge, an expected 2 days to 3 weeks)
- Mortality(Patients will be followed until three months after hospital discharge)
- Gait speed(Study completion, an average of 2 months (hospital discharge))
- Quality of life following hospital discharge(Three months after hospital discharge SF36)
- 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.)
- Side effects of mobilization protocol(During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.)
Investigators
Isabella Martins de Albuquerque
Professor DSc.
Universidade Federal de Santa Maria