<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/NCT03246425</url>
  </required_header>
  <id_info>
    <org_study_id>909804-2</org_study_id>
    <nct_id>NCT03246425</nct_id>
  </id_info>
  <brief_title>Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study</brief_title>
  <official_title>Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Upstate Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Upstate Medical University</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mechanical ventilation has been known to produce changes in the flow of blood through the&#xD;
      major blood vessels in the body. These changes may go undetected, but with continuous&#xD;
      arterial blood pressure measurements, changes in the arterial waveform can be visualized.&#xD;
      Although we know that these arterial pressure variations occur during mechanical ventilation,&#xD;
      little is known about the effects of various modes of mechanical ventilation on these&#xD;
      changes. The most common modes of ventilation used in ICU are Volume control, Pressure&#xD;
      control and Airway pressure release ventilation.&#xD;
&#xD;
      Objective We have designed a prospective randomized pilot study to determine the effects of&#xD;
      the commonly used ventilator modes on the arterial pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">September 12, 2016</start_date>
  <completion_date type="Actual">September 11, 2017</completion_date>
  <primary_completion_date type="Actual">September 11, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Stroke Volume Variation.</measure>
    <time_frame>For 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Pulse Pressure Variation</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Pulse Pressure Variation</measure>
    <time_frame>For 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Stroke Volume variation.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Critical Illness</condition>
  <condition>Hypovolemia</condition>
  <arm_group>
    <arm_group_label>1. Volume control- Pressure control- APRV- VPA group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2. Pressure control- APRV- Volume control- PAV group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>3. APRV- Volume control- pressure control- AVP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ventilator mode change</intervention_name>
    <description>The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed</description>
    <arm_group_label>1. Volume control- Pressure control- APRV- VPA group</arm_group_label>
    <arm_group_label>2. Pressure control- APRV- Volume control- PAV group</arm_group_label>
    <arm_group_label>3. APRV- Volume control- pressure control- AVP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitoring of blood pressure variation</intervention_name>
    <description>The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor</description>
    <arm_group_label>1. Volume control- Pressure control- APRV- VPA group</arm_group_label>
    <arm_group_label>2. Pressure control- APRV- Volume control- PAV group</arm_group_label>
    <arm_group_label>3. APRV- Volume control- pressure control- AVP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients 18 yrs of age and older, Patients on mechanical ventilation, Patients deeply&#xD;
        sedated in the ICU with RASS scores of atleast -3, Patients having an A-line for blood&#xD;
        pressure monitoring, Patients with stable hemodynamics.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with moderate-severe ARDS, Patients requiring high inspiratory oxygen&#xD;
        requirements, High peak inspiratory pressures requirement for ventilation, Presence of&#xD;
        arrhythmia, Patients with spontaneous breathing activity, Patients on weaning mode,&#xD;
        Patients having CHF or Cor pulmonale.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos J Lopez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University of New York - Upstate Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Hypovolemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03246425
org study id: 909804-2
nct id: NCT03246425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Mechanical ventilation has been known to produce changes in the flow of blood through the
      major blood vessels in the body. These changes may go undetected, but with continuous
      arterial blood pressure measurements, changes in the arterial waveform can be visualized.
      Although we know that these arterial pressure variations occur during mechanical ventilation,
      little is known about the effects of various modes of mechanical ventilation on these
      changes. The most common modes of ventilation used in ICU are Volume control, Pressure
      control and Airway pressure release ventilation.

      Objective We have designed a prospective randomized pilot study to determine the effects of
      the commonly used ventilator modes on the arterial pressure.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Stroke Volume Variation.
time frame: For 12 months
measure: The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Pulse Pressure Variation
time frame: 12 Months
measure: Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Pulse Pressure Variation
time frame: For 12 months
measure: Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Stroke Volume variation.
time frame: 12 months
arm group label: 1. Volume control- Pressure control- APRV- VPA group
arm group type: Active Comparator
arm group label: 2. Pressure control- APRV- Volume control- PAV group
arm group type: Active Comparator
arm group label: 3. APRV- Volume control- pressure control- AVP group
arm group type: Active Comparator
intervention type: Other
intervention name: Ventilator mode change
description: The enrolled subjects will be moved from the baseline mode to another mode of ventilation and the changes in the arterial pulse will be observed
arm group label: 1. Volume control- Pressure control- APRV- VPA group
arm group label: 2. Pressure control- APRV- Volume control- PAV group
arm group label: 3. APRV- Volume control- pressure control- AVP group
intervention type: Device
intervention name: Monitoring of blood pressure variation
description: The changes in the blood pressure will be measured in the form of Stroke Volume Variation using SVV using Vigileo (Edward Life sciences) monitor
arm group label: 1. Volume control- Pressure control- APRV- VPA group
arm group label: 2. Pressure control- APRV- Volume control- PAV group
arm group label: 3. APRV- Volume control- pressure control- AVP group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos J Lopez, MD
role: Principal Investigator
affiliation: State University of New York - Upstate Medical University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Critical Illness
mesh term: Hypovolemia