ICU Length of Stay, Muscle Thickness of the Quadriceps Femoris, Muscle Weakness, Quality of Life, Weaning Acceleration
Conditions
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.
Interventions
Patients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH & Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position.
Sponsors
Universidade Federal de Santa Maria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| Gait speed | Study completion, an average of 2 months (hospital discharge) | Gait speed will be measured by the six-meter gait speed test (GST) |
| 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 |
| 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 |
| 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). |
| 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. |
| Length of hospital stay | Patients will be followed until hospital discharge, an expected 4 to 6 weeks | — |
| Mortality | Patients will be followed until three months after hospital discharge | — |
| 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) |
Countries
Brazil
Outcome results
None listed