Neuromuscular Electrical Stimulation in Critically Ill Patients.

Rehabilitation Clinical Trial

Official title:

Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03815994
• Other study ID #: USP 2018-1
• Status: Suspended
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: January 29, 2021

Study information

• Verified date: February 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 31
• Est. completion date: January 29, 2021
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Rehabilitation

Intervention

Device:
• Neuromuscular Electrical Stimulation
This device produces a muscle contraction in response to a externally generated low-voltage electric impulse, which is conducted through electrodes placed on the skin over the muscle group to be stimulated.

Locations

Country	Name	City	State
Brazil	Clinics Hospital	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Resting energy expenditure (REE) from baseline and interventions.	Change of Resting energy expenditure (REE) will be evaluated by calorimetry	REE will be taken during the each intervention, it will be taken only the first day
Primary	Change of Oxygen consumption (VO2),from baseline and interventions.	Change of Oxygen consumption (VO2) will be evaluated by calorimetry	VO2 will be taken during the each intervention, it will be taken only the first day
Secondary	Change of Carbon dioxide production (VCO2) from baseline and interventions.	Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry	VCO2 will be taken during the each intervention, it will be taken only the first day