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

Polyneuropathy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02033057
• Other study ID #: Pi12/01018
• Status: Recruiting
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: January 9, 2014
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2012
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness
• Polyneuropathies
• Polyneuropathy

Intervention

Procedure:
• Muscular electrostimulation and percutaneus muscular biopsy.
Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politécnico La Fe.	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	time of weaning		everyday	Yes