<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815994</url>
  </required_header>
  <id_info>
    <org_study_id>USP 2018-1</org_study_id>
    <nct_id>NCT03815994</nct_id>
  </id_info>
  <brief_title>Neuromuscular Electrical Stimulation in Critically Ill Patients.</brief_title>
  <official_title>Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will investigate the effects of neuromuscular electrical stimulation (NMES) in&#xD;
      critically ill patients. The objective of this study will be investigate the effects of&#xD;
      neuromuscular electrical stimulation (NMES) in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will investigate the effects of neuromuscular electrical stimulation (NMES) in&#xD;
      critically ill patients. It will be a randomised crossover clinical trial. Thirty-one&#xD;
      patients will enrolled. Patients will be selected, randomly, to the intervention Protocol&#xD;
      (decubitus position with the limbs raised and NMES) and control (decubitus position with the&#xD;
      limbs raised without NMES).The patients will be allocated in Group 1 (intervention and&#xD;
      control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between&#xD;
      them.&#xD;
&#xD;
      The main outcome will be metabolic data. Linear mixed model will be used for analysis of&#xD;
      dependent variables and estimated values of the mean of the differences of each effect.&#xD;
&#xD;
      The results of this study will allow better understanding of the metabolic effects of NMES in&#xD;
      patients critically ill.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    This study had to be suspended due to COVID-19 Pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Anticipated">January 29, 2021</completion_date>
  <primary_completion_date type="Actual">January 6, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Oxygen consumption (VO2),from baseline and interventions.</measure>
    <time_frame>VO2 will be taken during the each intervention, it will be taken only the first day</time_frame>
    <description>Change of Oxygen consumption (VO2) will be evaluated by calorimetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Carbon dioxide production (VCO2) from baseline and interventions.</measure>
    <time_frame>VCO2 will be taken during the each intervention, it will be taken only the first day</time_frame>
    <description>Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of Resting energy expenditure (REE) from baseline and interventions.</measure>
    <time_frame>REE will be taken during the each intervention, it will be taken only the first day</time_frame>
    <description>Change of Resting energy expenditure (REE) will be evaluated by calorimetry</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">31</enrollment>
  <condition>Critical Care</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Experimental: group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuromuscular Electrical Stimulation</intervention_name>
    <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.</description>
    <arm_group_label>Experimental: group 1</arm_group_label>
    <arm_group_label>group 2</arm_group_label>
    <other_name>Functional Electrical Stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients that will be admitted to the intensive care unit&#xD;
&#xD;
          -  Hemodynamic stability&#xD;
&#xD;
          -  Mechanical ventilation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In general:&#xD;
&#xD;
               -  a. Pregnant women&#xD;
&#xD;
               -  b. Brain death&#xD;
&#xD;
               -  c. Neuromuscular diseases&#xD;
&#xD;
               -  d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the&#xD;
                  study protocol.&#xD;
&#xD;
          2. Contraindications for the use of NMES:&#xD;
&#xD;
               -  a. Fractures&#xD;
&#xD;
               -  b. Burns&#xD;
&#xD;
               -  c. Skin lesions&#xD;
&#xD;
               -  d. Systemic vascular impairment diseases such as systemic lupus erythematosus,&#xD;
                  thromboembolic disease, deep vein thrombosis (which was not therapeutically&#xD;
                  anticoagulated for a time greater than 36 hours)&#xD;
&#xD;
               -  e. Lower limb amputations&#xD;
&#xD;
               -  f. Cardiac pacemaker,&#xD;
&#xD;
               -  g. Thrombocytopenia less than 20,000/mm3&#xD;
&#xD;
               -  h. BMI greater than 35 kg/m2&#xD;
&#xD;
               -  i. Important lower extremity oedema&#xD;
&#xD;
               -  j. Agitation and/or signs of pain during the electrical stimulation.&#xD;
&#xD;
          3. Contraindications to begin or continue NMES procedure:&#xD;
&#xD;
               -  a. Mean arterial blood pressure less than 65 mmHg&#xD;
&#xD;
               -  b. Use of vasopressor &gt;50% of themaximum dose (dopamine &gt;12.5 μg/kg per minute;&#xD;
                  vasopressin &gt;0.02U/min and norepinephrine &gt;1 μg/kg per minute),&#xD;
&#xD;
               -  c. Heart rate &lt;50 or &gt;140bpm&#xD;
&#xD;
               -  d. Arrhythmias with hemodynamic consequences&#xD;
&#xD;
               -  e. Myocardial ischemia,&#xD;
&#xD;
               -  f. Temperature &lt;34 or &gt;39oC&#xD;
&#xD;
               -  g. Intracranial pressure &gt;20 cmH2O&#xD;
&#xD;
               -  h. Decrease in 10% of SpO2 baseline value or &lt;88% for more than one minute.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ada C Gastaldi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ribeirao Preto Medicine School-University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinics Hospital</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ada Clarice Gastaldi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Physical therapy modalities,</keyword>
  <keyword>Electric stimulation therapy</keyword>
  <keyword>Indirect calorimetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification, will be available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will be available immediately following publication and for five years.</ipd_time_frame>
    <ipd_access_criteria>The data will be available from the principal investigator upon reasonable request.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815994
org study id: USP 2018-1
nct id: NCT03815994
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Change of Oxygen consumption (VO2),from baseline and interventions.
time frame: VO2 will be taken during the each intervention, it will be taken only the first day
description: Change of Oxygen consumption (VO2) will be evaluated by calorimetry
measure: Change of Carbon dioxide production (VCO2) from baseline and interventions.
time frame: VCO2 will be taken during the each intervention, it will be taken only the first day
description: Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry
measure: Change of Resting energy expenditure (REE) from baseline and interventions.
time frame: REE will be taken during the each intervention, it will be taken only the first day
description: Change of Resting energy expenditure (REE) will be evaluated by calorimetry
arm group label: Experimental: group 1
arm group type: Experimental
description: Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
arm group label: group 2
arm group type: Sham Comparator
description: Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation.
intervention type: Device
intervention name: Neuromuscular Electrical Stimulation
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.
arm group label: Experimental: group 1
arm group label: group 2
other name: Functional Electrical Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ada C Gastaldi, PhD
role: Principal Investigator
affiliation: Ribeirao Preto Medicine School-University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ada Clarice Gastaldi
investigator title: Principal Investigator
mesh term: Critical Illness
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification, will be available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will be available immediately following publication and for five years.
ipd access criteria: The data will be available from the principal investigator upon reasonable request.