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Evaluation of a new protocol of neuromuscular electrical stimulation.

Evaluation of safety and feasibility of a neuromuscular electrical stimulation protocol in ICU: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-57355w
Enrollment
Unknown
Registered
2015-06-23
Start date
2013-02-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous system diseases, musculoskeletal diseases, atrophy

Interventions

Patients of both sexes who were selected for the study will be randomized to the control group or the experimental group. Each group will have 20 subjects. The control group will be submitted dayly t
Device
E05.723.402
E01.370.405
E05.723.402.201

Sponsors

Associação Teresinense de Ensino SC LTDA
Lead Sponsor
Paulo Eugênio Silva
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years undergoing mechanical ventilation; APACHE II Score higher than 13. Target sample of 40 patients.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Primary outcomes 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. ;Outcomes found: there was no statistical difference between the control group and the experimental group, showing that the stimulation was safe.

Secondary

MeasureTime frame
Secondary outcome 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. ;Outcome found: the average time spent in the therapy per patient in the experimental group was 120 minutes demonstrating that the conduct is clinically infeasible.

Countries

Brazil

Contacts

Public ContactPaulo Silva

Universidade de Brasília

pauloeugenio@ymail.com+55(61)96864850

Outcome results

None listed

Source: REBEC (via WHO ICTRP)