Neuromuscular Electrical Stimulation in Critically Ill Patients.

NCT ID: NCT03815994

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2021-01-29

Brief 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.

Detailed 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.

Conditions

Critical Care; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental: group 1

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

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: DEVICE

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.

group 2

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

Group Type: SHAM_COMPARATOR

Neuromuscular Electrical Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Functional Electrical Stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ada Clarice Gastaldi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ada C Gastaldi, PhD

Role: PRINCIPAL_INVESTIGATOR

Ribeirao Preto Medicine School-University of São Paulo

Locations

Clinics Hospital

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.

Reference Type: DERIVED

PMID: 35176099 (View on PubMed)

Other Identifiers

USP 2018-1

Identifier Type: -

Identifier Source: org_study_id