Neuromuscular Electrical Stimulation in Critically Ill Patients.

University of Sao Paulo

Status: Suspended

Conditions: Rehabilitation; Critical Care

Treatments: Device: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03815994

USP 2018-1

Details and patient eligibility

About

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.

Full description

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.

The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.

Enrollment: 31 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients that will be admitted to the intensive care unit
• Hemodynamic stability
• Mechanical ventilation.

Exclusion criteria

1. In general:

   • a. Pregnant women
   • b. Brain death
   • c. Neuromuscular diseases
   • d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.

2. Contraindications for the use of NMES:

   • a. Fractures
   • b. Burns
   • c. Skin lesions
   • d. Systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours)
   • e. Lower limb amputations
   • f. Cardiac pacemaker,
   • g. Thrombocytopenia less than 20,000/mm3
   • h. BMI greater than 35 kg/m2
   • i. Important lower extremity oedema
   • j. Agitation and/or signs of pain during the electrical stimulation.

3. Contraindications to begin or continue NMES procedure:

   • a. Mean arterial blood pressure less than 65 mmHg
   • b. Use of vasopressor >50% of themaximum dose (dopamine >12.5 μg/kg per minute; vasopressin >0.02U/min and norepinephrine >1 μg/kg per minute),
   • c. Heart rate <50 or >140bpm
   • d. Arrhythmias with hemodynamic consequences
   • e. Myocardial ischemia,
   • f. Temperature <34 or >39oC
   • g. Intracranial pressure >20 cmH2O
   • h. Decrease in 10% of SpO2 baseline value or <88% for more than one minute.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Experimental: group 1

Experimental group

Description:

Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.

Treatment:

Device: Neuromuscular Electrical Stimulation

group 2

Sham Comparator group

Description:

Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation.

Treatment:

Device: Neuromuscular Electrical Stimulation