Evaluation of a new protocol of neuromuscular electrical stimulation.
Not Applicable
- Conditions
- ervous system diseases, musculoskeletal diseases, atrophyC23.300.070
- Registration Number
- RBR-57355w
- Lead Sponsor
- Associação Teresinense de Ensino SC LTDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Patients older than 18 years undergoing mechanical ventilation; APACHE II Score higher than 13.
Target sample of 40 patients.
Exclusion Criteria
Pregnancy; obesity (body mass index >35 kg/m2); preexisting neuromuscular disease (e.g. myasthenia Gravis; Guillain-Barré disease); diseases with systemic vascular involvement such as systemic lupus erythematosus; bone fractures
or skin lesions.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes<br>The primary outcomes are changes in CPK levels, lactate and central venous O2 saturation (ScvO2). For this purpose, blood samples will be taken at the central venous access devices daily. It is expected that CPK levels to rise as well as the lactate and central venous oxygen saturation levels remain stable.Furthermore, it is expected that after the electrical stimulation, CPK levels do not exceed 1000 IU/L, lactate levels do not exceed 4 mmol/L and the percentages of SvcO2 do not fall below 65%. These values will be compared to the values found in the control group.<br> <br>;Outcomes found: <br><br>there was no statistical difference between the control group and the experimental group, showing that the stimulation was safe.
- Secondary Outcome Measures
Name Time Method Secondary outcome<br>The secondary endpoint will be the therapy feasibility. This will be evaluated by the time spent in the therapy. It is believed that the time spent in this therapy is high making it impossible to carry out with the current equipments.<br><br>;Outcome found: <br><br>the average time spent in the therapy per patient in the experimental group was 120 minutes demonstrating that the conduct is clinically infeasible.