<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/NCT02224352</url>
  </required_header>
  <id_info>
    <org_study_id>NSF-1417104</org_study_id>
    <nct_id>NCT02224352</nct_id>
  </id_info>
  <brief_title>VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning</brief_title>
  <official_title>VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edward Hines Jr. VA Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RML Specialty Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Edward Hines Jr. VA Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Over one million patients in the US are estimated to undergo mechanical&#xD;
      ventilation every year, and approximately 300,000 of them fail attempts at weaning. The&#xD;
      morbidity and mortality of these patients is greater than in patients who are successfully&#xD;
      weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation&#xD;
      have the potential to benefit society both in terms of human suffering and cost.&#xD;
&#xD;
      Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by&#xD;
      recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs&#xD;
      relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment&#xD;
      can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during&#xD;
      weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation&#xD;
      are in a catabolic state raises the possibility that strategies designed to produce an early&#xD;
      recruitment, and improve the strength, of the expiratory muscles could improve weaning&#xD;
      outcomes in difficult to wean patients.&#xD;
&#xD;
      The current investigation, which will be conducted in healthy subjects and in ambulatory&#xD;
      patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1&#xD;
      and 2), and in patients who are difficult to wean from mechanical ventilation at RML&#xD;
      Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel&#xD;
      triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular&#xD;
      electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study&#xD;
      the physiological (respiratory) responses to such stimulation in assisting respiration in&#xD;
      healthy subjects, in ambulatory patients with COPD and in patients requiring pronged&#xD;
      mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
    <description>Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Error rate</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
    <description>Number of false positive stimulation triggers over the total number of breaths taken.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tidal volume</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minute ventilation</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Esophageal pressure time product</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trans diaphragmatic pressure time product</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tension time index of the diaphragm</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of tidal change in Pga to tidal change in Pes</measure>
    <time_frame>10 minutes of resting breathing</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>COPD</condition>
  <condition>Weaning Failure</condition>
  <arm_group>
    <arm_group_label>Single-Arm Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Functional neuromuscular electrical stimulation of abdominal-wall muscles triggered by an airway pressure signal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Functional neuromuscular electrical stimulation</intervention_name>
    <arm_group_label>Single-Arm Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Aim 1 and Aim 2:Healthy Subjects and Ambulatory COPD Patients Studied at Hines VAH&#xD;
&#xD;
        Healthy subjects (Hines VAH), Inclusion criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  No history of acute or chronic respiratory disease, cardiac or neuromuscular disease.&#xD;
&#xD;
        Ambulatory COPD patients (Hines VAH), Inclusion criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Chronic airway obstruction defined as forced expiratory volume in one second (FEV1) of&#xD;
             70% predicted or less, ratio of forced expiratory volume in one second to forced vital&#xD;
             capacity (FEV1/FVC) of 0.7 or less&#xD;
&#xD;
          -  Stable clinical condition without an exacerbation during the preceding four weeks&#xD;
&#xD;
        Aim 3: Patients being weaned from prolonged mechanical ventilation (RML Specialty&#xD;
        Hospital), Inclusion criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  History of neuromuscular disease&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m2&#xD;
&#xD;
          -  Patients who have received mechanical ventilation for at least 14 days and the primary&#xD;
             physician judges the patient is ready to start weaning&#xD;
&#xD;
          -  Able to breathe spontaneously for more than 5 minutes and less than 12 hours&#xD;
&#xD;
          -  Clinically stable: oxygen saturation &gt; 90% with a fractional inspired oxygen ≤ 0.40,&#xD;
             external PEEP ≤ 5 cm H2O, temperature ranging from 35.5 to 38.5Co, no intravenous&#xD;
             administration of vasoactive agents.&#xD;
&#xD;
        Additional inclusion/exclusion criteria for all potential participants&#xD;
&#xD;
          -  Subjects with implanted electronic devices - such as cardiac pacemakers,&#xD;
             defibrillators and intrathecal pumps - will be excluded because NMES could cause&#xD;
             malfunction of those devices.&#xD;
&#xD;
          -  Only subjects with intact abdominal-wall skin will be enrolled because NMES can cause&#xD;
             discomfort when applied over skin that is irritated or on open wounds.&#xD;
&#xD;
          -  Pregnancy will be a contraindication to participate in the study because it is unknown&#xD;
             whether the application of NMES to the abdominal or lumbar area during pregnancy may&#xD;
             produce adverse effects.&#xD;
&#xD;
          -  Unable to comprehend and interact in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franco Laghi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Staff Physician</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Franco Laghi, MD</last_name>
    <phone>708/202-2705</phone>
    <email>Franco.Laghi@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hameeda Shaikh, MD</last_name>
    <phone>708/202-2705</phone>
    <email>Hameeda.Shaikh@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Edward G. Hines Jr., VA Hospital</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franco Laghi, MD</last_name>
      <phone>708-202-2705</phone>
      <email>Franco.Laghi@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Susan O'Connell, RN,MHA</last_name>
      <phone>708/202-7218</phone>
      <email>Susan.Oconnell@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Franco Laghi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hameeda Shaikh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>RML Specialty Hospital</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Franco Laghi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hameeda Shaikh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Edward Hines Jr. VA Hospital</investigator_affiliation>
    <investigator_full_name>Franco Laghi, MD</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Electric Stimulation</keyword>
  <keyword>Respiration</keyword>
  <keyword>Abdominal wall</keyword>
  <keyword>Lung Diseases</keyword>
  <keyword>Respiratory Tract Diseases</keyword>
  <keyword>COPD</keyword>
  <!-- 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/NCT02224352
org study id: NSF-1417104
nct id: NCT02224352
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Background: Over one million patients in the US are estimated to undergo mechanical
      ventilation every year, and approximately 300,000 of them fail attempts at weaning. The
      morbidity and mortality of these patients is greater than in patients who are successfully
      weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation
      have the potential to benefit society both in terms of human suffering and cost.

      Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by
      recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs
      relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment
      can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during
      weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation
      are in a catabolic state raises the possibility that strategies designed to produce an early
      recruitment, and improve the strength, of the expiratory muscles could improve weaning
      outcomes in difficult to wean patients.

      The current investigation, which will be conducted in healthy subjects and in ambulatory
      patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1
      and 2), and in patients who are difficult to wean from mechanical ventilation at RML
      Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel
      triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular
      electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study
      the physiological (respiratory) responses to such stimulation in assisting respiration in
      healthy subjects, in ambulatory patients with COPD and in patients requiring pronged
      mechanical ventilation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Sensitivity
time frame: 10 minutes of resting breathing
description: Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.
measure: Error rate
time frame: 10 minutes of resting breathing
description: Number of false positive stimulation triggers over the total number of breaths taken.
measure: Tidal volume
time frame: 10 minutes of resting breathing
measure: Respiratory rate
time frame: 10 minutes of resting breathing
measure: Minute ventilation
time frame: 10 minutes of resting breathing
measure: Esophageal pressure time product
time frame: 10 minutes of resting breathing
measure: Trans diaphragmatic pressure time product
time frame: 10 minutes of resting breathing
measure: Tension time index of the diaphragm
time frame: 10 minutes of resting breathing
measure: Ratio of tidal change in Pga to tidal change in Pes
time frame: 10 minutes of resting breathing
arm group label: Single-Arm Study
arm group type: Experimental
description: Functional neuromuscular electrical stimulation of abdominal-wall muscles triggered by an airway pressure signal
intervention type: Device
intervention name: Functional neuromuscular electrical stimulation
arm group label: Single-Arm Study
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Franco Laghi, MD
role: Principal Investigator
affiliation: Staff Physician
last name: Franco Laghi, MD
phone: 708/202-2705
email: Franco.Laghi@va.gov
last name: Hameeda Shaikh, MD
phone: 708/202-2705
email: Hameeda.Shaikh@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Edward Hines Jr. VA Hospital
investigator full name: Franco Laghi, MD
investigator title: Staff Physician