Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
Primary Purpose
Polyneuropathy
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Muscular electrostimulation and percutaneus muscular biopsy.
Sponsored by
About this trial
This is an interventional treatment trial for Polyneuropathy focused on measuring Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
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/m2.
- Pregnant.
- Epilepsia.
- Use muscular blocks.
Sites / Locations
- Hospital Universitario y Politécnico La Fe.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Muscular electrostimulation.
Arm Description
The interventions is muscular electrostimulation.
Outcomes
Primary Outcome Measures
muscular weakness
We measure the muscular weakness, with the medical research council scale.
Secondary Outcome Measures
time of weaning
Full Information
NCT ID
NCT02033057
First Posted
January 8, 2014
Last Updated
January 9, 2014
Sponsor
Hospital Universitario La Fe
1. Study Identification
Unique Protocol Identification Number
NCT02033057
Brief Title
Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathy
Keywords
Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscular electrostimulation.
Arm Type
Experimental
Arm Description
The interventions is muscular electrostimulation.
Intervention Type
Procedure
Intervention Name(s)
Muscular electrostimulation and percutaneus muscular biopsy.
Intervention Description
Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.
Primary Outcome Measure Information:
Title
muscular weakness
Description
We measure the muscular weakness, with the medical research council scale.
Time Frame
at the time of weaning, 30 days after extubation and one year after extubation.
Secondary Outcome Measure Information:
Title
time of weaning
Time Frame
everyday
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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/m2.
Pregnant.
Epilepsia.
Use muscular blocks.
Facility Information:
Facility Name
Hospital Universitario y Politécnico La Fe.
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Ramirez
Phone
0034619031958
First Name & Middle Initial & Last Name & Degree
Paula Rami-rez
12. IPD Sharing Statement
Learn more about this trial
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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