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Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.

Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02033057
Enrollment
40
Registered
2014-01-10
Start date
2012-10-31
Completion date
2014-10-31
Last updated
2014-01-10

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

Conditions

Polyneuropathy

Keywords

Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.

Brief summary

Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of Universitarian hospital La Fe in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.

Interventions

PROCEDUREMuscular electrostimulation and percutaneus muscular biopsy.

Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.

Sponsors

Hospital Universitario La Fe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients older than 18 years. * Sedated and mechanically ventilated critically ill patients, more than 48 hours.

Exclusion criteria

* Body mass index \> 45 or \< 20 kg/m2. * Pregnant. * Epilepsia. * Use muscular blocks.

Design outcomes

Primary

MeasureTime frameDescription
muscular weaknessat the time of weaning, 30 days after extubation and one year after extubation.We measure the muscular weakness, with the medical research council scale.

Secondary

MeasureTime frame
time of weaningeveryday

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026