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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.

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ClinicalTrials.gov Identifier: NCT02033057
Recruitment Status : Unknown
Verified October 2012 by Paula Ramirez, Hospital Universitario La Fe.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Paula Ramirez, Hospital Universitario La Fe

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.

Condition or disease Intervention/treatment Phase
Polyneuropathy Procedure: Muscular electrostimulation and percutaneus muscular biopsy. Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
Study Start Date : October 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Muscular electrostimulation.
The interventions is muscular electrostimulation.
Procedure: Muscular electrostimulation and percutaneus muscular biopsy.
Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. time of weaning [ Time Frame: everyday ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/m2.
  • Pregnant.
  • Epilepsia.
  • Use muscular blocks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033057


Locations
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Spain
Hospital Universitario y Politécnico La Fe. Recruiting
Valencia, Spain, 46026
Contact: Paula Ramirez    0034619031958      
Principal Investigator: Paula Rami-rez         
Sponsors and Collaborators
Hospital Universitario La Fe

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Responsible Party: Paula Ramirez, doctor, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT02033057    
Other Study ID Numbers: Pi12/01018
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: October 2012
Keywords provided by Paula Ramirez, Hospital Universitario La Fe:
Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
Additional relevant MeSH terms:
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Muscle Weakness
Polyneuropathies
Critical Illness
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms