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Neuromuscular evaluation method

Feasibility and safety of muscle assessment by FES-Cycling - FES-Cycling Functional electrical stimulation associated to cyclergometry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-10gyv7wn
Enrollment
Unknown
Registered
2022-04-06
Start date
2021-12-01
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

Muscle weakness

Interventions

Functional electrical stimulation associated with cyclorgometry will be performed in 30 patients undergoing mechanical ventilation in a single evaluation moment, in order to obtain peripheral muscle p
SP4.122.006.062
E05.723.402

Sponsors

Thainá de Gomes Figueiredo
Lead Sponsor
Pronto-Socorro Cardiológico de Pernambuco
Collaborator
Real Hospital Portugues de Beneficencia de Pernambuco
Collaborator
Industria Brasileira de Equipamentos Medicos Ltda
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The study included individuals over 18 years of age; of both sexes; quadriparetic; mechanically ventilated

Exclusion criteria

Exclusion criteria: Patients with hemodynamic instability (mean arterial pressure greater than 65 or greater than 110 millimeters of mercury) were excluded; patients with musculoskeletal deficiencies or deficiencies that prevent the performance of Fes-Cycling

Design outcomes

Primary

MeasureTime frame
Assess Safety through blood pressure, heart rate, peripheral oxygen saturation, venous oxygen saturation and blood lactate It is expected to find the maintenance of hemodynamic parameters (blood pressure and heart rate) and peripheral oxygen saturation, measured before and immediately after the evaluation protocol, as well as venous oxygen saturation and blood lactate. Blood creatine phosphokinase was measured before (baseline) and 24, 48 and 72 hours after the test and it is also expected that it will not rise to May 190;Evaluate the feasibility through the time spent to carry out the entire evaluation protocol recorded, which is divided into: 1) patient preparation time (fit the patient to the equipment, electrode placement, cable connection, configuration of width and pulse intensity); 2) trip/stop angle adjustment time; 3) test execution time (execution of the 90 cyclic movements); and 4) time for equipment release (disconnect cables, remove electrodes and remove equipment). It is expected to find that the time taken to carry out the entire assessment protocol recorded to assess feasibility, taking the shortest time possible and feasible for use in clinical practice (approximately half an hour). The total time was divided into: 1) patient preparation time (fit the patient to the equipment, placement of electrodes, cable connection, configuration of pulse width and intensity parameters); 2) trip/stop angle adjustment time; 3) test execution time (execution of the 90 cyclic movements); and 4) time to release the equipment (disconnect cables, remove electrodes and remove equipment). The number of patients with very visible, barely visible or not visible muscle contraction was also recorded;Evaluate muscle performance through maximum power, torque reached and stimulation cost. It is expected to find reduced values in patients undergoing mechanical ventilation admitted to the ICU when compared to healthy individuals

Secondary

MeasureTime frame
Evaluate clinical outcomes such as duration of mechanical ventilation, length of stay in the ICU, death, hospital discharge. It is expected to find that patients with worse muscle performance evaluated have longer mechanical ventilation times and ICU stay, as well as higher death rates when compared with healthy individuals

Countries

Brazil

Contacts

Public ContactMurillo Frazão

Industria Brasileira de Equipamentos Medicos Ltda

murillo.frazao@gmail.com+55(31) 81 99362-2322

Outcome results

None listed

Source: REBEC (via WHO ICTRP)