Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

Pericles Almeida Delfino Duarte

Status: Completed

Conditions: Respiration, Artificial; Critical Illness Myopathy

Treatments: Procedure: Electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03352102

134673

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Diaphragm Group (DG)

Experimental group

Description:

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.

Treatment:

Procedure: Electrical stimulation

Quadriceps Group (QG)

Active Comparator group

Description:

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.

Treatment:

Procedure: Electrical stimulation

Control Group (CG)

No Intervention group

Description:

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.