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Clinical Trials/NCT02033057
NCT02033057
Unknown
Phase 4

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

Hospital Universitario La Fe1 site in 1 country40 target enrollmentOctober 2012
ConditionsPolyneuropathy

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Polyneuropathy
Sponsor
Hospital Universitario La Fe
Enrollment
40
Locations
1
Primary Endpoint
muscular weakness
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paula Ramirez

doctor

Hospital Universitario La Fe

Eligibility Criteria

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/m
  • Pregnant.
  • Epilepsia.
  • Use muscular blocks.

Outcomes

Primary Outcomes

muscular weakness

Time Frame: at 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 Outcomes

  • time of weaning(everyday)

Study Sites (1)

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