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

NCT ID: NCT02033057

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Muscular electrostimulation.

The interventions is muscular electrostimulation.

Group Type: EXPERIMENTAL

Muscular electrostimulation and percutaneus muscular biopsy.

Intervention Type: PROCEDURE

Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.

Interventions

Muscular electrostimulation and percutaneus muscular biopsy.

Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Fe

OTHER

Sponsor Role: lead

Responsible Party

Paula Ramirez

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario y Politécnico La Fe.

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Paula Ramirez

Role: primary

0034619031958

Other Identifiers

Pi12/01018

Identifier Type: -

Identifier Source: org_study_id