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Neuromuscular Electrical Stimulation in Critically Ill Patients.

Primary Purpose

Critical Care, Rehabilitation

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Care focused on measuring Physical therapy modalities,, Electric stimulation therapy, Indirect calorimetry

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinics Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental: group 1

group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of Oxygen consumption (VO2),from baseline and interventions.
Change of Oxygen consumption (VO2) will be evaluated by calorimetry

Secondary Outcome Measures

Change of Carbon dioxide production (VCO2) from baseline and interventions.
Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry

Full Information

First Posted
November 13, 2018
Last Updated
February 2, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03815994
Brief Title
Neuromuscular Electrical Stimulation in Critically Ill Patients.
Official Title
Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Suspended
Why Stopped
This study had to be suspended due to COVID-19 Pandemic.
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
January 29, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Care, Rehabilitation
Keywords
Physical therapy modalities,, Electric stimulation therapy, Indirect calorimetry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: group 1
Arm Type
Experimental
Arm Description
Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
Arm Title
group 2
Arm Type
Sham Comparator
Arm Description
Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation
Other Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Oxygen consumption (VO2),from baseline and interventions.
Description
Change of Oxygen consumption (VO2) will be evaluated by calorimetry
Time Frame
VO2 will be taken during the each intervention, it will be taken only the first day
Secondary Outcome Measure Information:
Title
Change of Carbon dioxide production (VCO2) from baseline and interventions.
Description
Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry
Time Frame
VCO2 will be taken during the each intervention, it will be taken only the first day
Other Pre-specified Outcome Measures:
Title
Change of Resting energy expenditure (REE) from baseline and interventions.
Description
Change of Resting energy expenditure (REE) will be evaluated by calorimetry
Time Frame
REE will be taken during the each intervention, it will be taken only the first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients that will be admitted to the intensive care unit Hemodynamic stability Mechanical ventilation. Exclusion Criteria: 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. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada C Gastaldi, PhD
Organizational Affiliation
Ribeirao Preto Medicine School-University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics Hospital
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35176099
Citation
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.
Results Reference
derived

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Neuromuscular Electrical Stimulation in Critically Ill Patients.

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