The Impact of Early Mobilization Protocol in Patients in the ICU
- Conditions
- Muscle Thickness of the Quadriceps FemorisMuscle WeaknessICU Length of StayQuality of LifeWeaning Acceleration
- Interventions
- Other: Early mobilization protocol
- Registration Number
- NCT01769846
- Lead Sponsor
- Universidade Federal de Santa Maria
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Mobilization protocol 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.
- Primary Outcome Measures
Name Time Method Muscle thickness (MT) of the quadriceps femoris. 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. 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 Outcome Measures
Name Time Method Gait speed Study completion, an average of 2 months (hospital discharge) Gait speed will be measured by the six-meter gait speed test (GST)
Quality of life following hospital discharge Three months after hospital discharge SF36 Quality of life will be measured by a questionnaire 36-item Short Form Health Survey
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 cross-sectional area will be assessed by ultrasonography (baseline and 14 day).
Rectus femoris and vastus intermedius thickness. Change from baseline at 14 day of ICU admission, an average of 1 month. Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography (baseline and 14 day).
Peripheral muscle strength of the lower limbs Study completion, an average of 2 months (hospital discharge) Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test
Vastus intermedius, rectus femoris and diaphragm echo intensity. Change from baseline at 14 day of ICU admission, an average of 1 month. Vastus intermedius, rectus femoris and diaphragm echo intensity will be assessed by ultrasonography (baseline and 14 day)
Muscle strength First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month. Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.
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. Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Response in peripheral oxygen saturation.
Trial Locations
- Locations (1)
University Hospital of Santa Maria
🇧🇷Santa Maria, Rio Grande Do Sul, Brazil