Neuromuscular Electrical Stimulation in Critically Ill Patients.

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

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.

Study Overview

• Status: Suspended
• Conditions: Rehabilitation; Critical Care
• Intervention / Treatment: Device: Neuromuscular Electrical Stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • Clinics Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental: group 1; Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.	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.; Other Names: Functional Electrical Stimulation
SHAM_COMPARATOR: group 2; Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation.	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.; Other Names: Functional Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Ada C Gastaldi, PhD, Ribeirao Preto Medicine School-University of São Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2018
• Primary Completion (ACTUAL): January 6, 2020
• Study Completion (ANTICIPATED): January 29, 2021

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (ACTUAL): January 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Indirect calorimetry; Electric stimulation therapy; Physical therapy modalities,
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: USP 2018-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification, will be available.
• IPD Sharing Time Frame: The data will be available immediately following publication and for five years.
• IPD Sharing Access Criteria: The data will be available from the principal investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No