Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

Study Overview
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Brief Summary
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Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Detailed Description
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Objective: Evaluate the effectiveness of the Neuro Muscular Electrical Stimulation therapy in quadriceps versus diaphragm subjects on mechanical ventilation (MV). Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Official Title
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Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: a Pilot Study.

Conditions
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Critical Illness Myopathy, Respiration, Artificial

Intervention / Treatment
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* Procedure: Electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or more 24 hours of MV or more Exclusion Criteria: Hemodynamic instability, pregnancy, body mass index(BMI) >35 kg/m2, history of neuromuscular disease at admission, brain death, diseases with systemic vascular involvement, bone fractures, use of an internal or external fixator, skin lesions, end-stage cancer, use of pacemakers, spinal injuries, or inability to receive an Medical Research Council score because of the cognitive state.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diaphragm Group (DG)<br>subjects who received conventional physical therapy once a day, plus a daily session of electrical stimulation in the diaphragm. Intervention: Electrical stimulation of the diaphragm. | Procedure: Electrical stimulation<br>* Neuromuscular electrical stimulation therapy was performed<br>|
| Active Comparator: Quadriceps Group (QG)<br>subjects who also received conventional physical therapy once a day, plus a daily session of electrical stimulation in the quadriceps. Intervention: Electrical stimulation of the quadriceps. | Procedure: Electrical stimulation<br>* Neuromuscular electrical stimulation therapy was performed<br>|
| No Intervention: Control Group (CG)<br>subjects who received regular treatment, i.e., conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day, including weekend, during their stay in the ICU. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU and Hospital length of stay | Length of stay (in days) in ICU and in hospitalization | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electric Stimulation, Intensive Care Units, Mechanical Ventilation, Ventilator Weaning