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

NCT02033057 | Unknown Phase 4

• 1 other identifier: Pi12/01018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• muscular weakness

  We measure the muscular weakness, with the medical research council scale.

  at the time of weaning, 30 days after extubation and one year after extubation.

Secondary Outcomes (1)

• time of weaning

  everyday

Study Arms (1)

Muscular electrostimulation.

EXPERIMENTAL

The interventions is muscular electrostimulation.

Procedure: Muscular electrostimulation and percutaneus muscular biopsy.

Interventions

Muscular electrostimulation and percutaneus muscular biopsy. PROCEDURE

Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.

Muscular electrostimulation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitario y Politécnico La Fe.

Valencia, Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Polyneuropathies; Muscle Weakness

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 10, 2014

Record last verified: 2012-10

Locations

ES (1)