xml: <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/NCT06006208</url>
    </required_header>
    <id_info>
      <org_study_id>iRISID-2022-1315</org_study_id>
      <nct_id>NCT06006208</nct_id>
    </id_info>
    <brief_title>AMBU Bag Manual Ventilation vs. Transport Ventilator Mechanical Ventilation for Transport</brief_title>
    <official_title>Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should we Use a Ventilator?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Thomas Jefferson University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a clinical trial to compare the oxygenation and ventilation performance between&#xD;
        manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Following cardiac surgery, patients often require ventilation during transport to the&#xD;
        intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC.&#xD;
        MD, USA) is utilized, but some patients need mechanical ventilation due to concern for&#xD;
        oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation&#xD;
        over manual ventilation is determined on a case-by-case basis, mostly based on providers'&#xD;
        experiences or surgical request, because currently there is no clear clinical evidence behind&#xD;
        that. With this clinical study, the investigators intend to build up clinical evidence by&#xD;
        comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms:&#xD;
        manual ventilation using AMBU bag arm and mechanical ventilation using a transport&#xD;
        ventilator.&#xD;
  &#xD;
        Objective: In this study, the investigators plan to compare the effects of transport&#xD;
        ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation,&#xD;
        ventilation, biventricular function, and hemodynamics. This is a two-arm study.&#xD;
  &#xD;
          1. To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function,&#xD;
             and hemodynamics (including blood pressure, heart rate, pulmonary artery pressure and&#xD;
             central venous pressure) in the AMBU bag and Hamilton transport ventilator groups. The&#xD;
             investigators hypothesize that using the Hamilton transport ventilator will show a&#xD;
             smaller change in P/F ratio, hemodynamics, and biventricular function compared to the&#xD;
             AMBU bag group. If true, these findings would support using the Hamilton ventilator for&#xD;
             transport in appropriate surgical patients.&#xD;
  &#xD;
          2. To perform &quot;in-vitro&quot; flow analysis using a flow analyzer analyzer (CITREX H5:&#xD;
  &#xD;
        Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy&#xD;
        of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different&#xD;
        resistance and compliance settings of the lung simulator&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>After IRB approval and obtaining a written informed consent, patients will be randomly assigned to the one of the following 2 arms. However, AMBU bag arm patients may be switched to Hamilton C1 at an anesthesia provider's discretion based on post cardiopulmonary bypass right ventricular function, PaO2/FiO2, and PaCO2. These patients will be excluded from the AMBU bag arm.&#xD;
  Arm 1: AMBU bag manual ventilation during transport to the ICU Arm 2: Hamilton C1 ventilator during transport to the ICU</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The patients will be randomly assigned to 2 arms above and the patients are not informed about which arm they are assigned.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The visual scale in changes in left ventricular function</measure>
      <time_frame>First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.</time_frame>
      <description>Within-group and between-group changes in visual assessment of left ventricular function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The visual scale in changes in right ventricular function</measure>
      <time_frame>First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.</time_frame>
      <description>Within-group and between-group changes in visual assessment of right ventricular cardiac function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The changes in PaO2/FiO2 (P/F ratio)</measure>
      <time_frame>First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.</time_frame>
      <description>The changes in PaO2/FiO2 (P/F ratio) pre and post transport to ICU. P/F ratio will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in PaCO2</measure>
      <time_frame>First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.</time_frame>
      <description>The changes in PaCO2 pre and post transport to ICU. PaCO2 will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Oxygenation</condition>
    <condition>Manual Ventilation</condition>
    <condition>Mechanical Ventilation</condition>
    <condition>Point of Care Ultrasound</condition>
    <condition>Cardiac Function Disturbance Postoperative</condition>
    <arm_group>
      <arm_group_label>Arm 1: AMBU bag manual ventilation during transport to the ICU</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2: Hamilton C1 ventilator during transport to the ICU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hamilton C1 ventilator during transport to the ICU</intervention_name>
      <description>Instead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU</description>
      <arm_group_label>Arm 2: Hamilton C1 ventilator during transport to the ICU</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years old (any gender or race)&#xD;
  &#xD;
            -  Cardiac surgery&#xD;
  &#xD;
            -  Require postoperative mechanical ventilation and care in the ICU.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients' refusal&#xD;
  &#xD;
            -  Extubation in OR&#xD;
  &#xD;
            -  On mechanical circulatory support&#xD;
  &#xD;
            -  Requirement for postoperative therapy with inhaled pulmonary vasodilators&#xD;
               (epoprostenol (FLOLAN), inhaled nitric oxide, etc.)&#xD;
  &#xD;
            -  Severe RV dysfunction with preoperative echocardiography&#xD;
  &#xD;
            -  Contraindication to TEE and pulmonary artery catheter.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Thomas Jefferson University</investigator_affiliation>
      <investigator_full_name>Yoshihisa Morita, MD</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>ventilator</keyword>
    <keyword>point of care ultrasound</keyword>
    <keyword>transport</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006208
  org study id: iRISID-2022-1315
  nct id: NCT06006208
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  This is a clinical trial to compare the oxygenation and ventilation performance between
        manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.
  Following cardiac surgery, patients often require ventilation during transport to the
        intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC.
        MD, USA) is utilized, but some patients need mechanical ventilation due to concern for
        oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation
        over manual ventilation is determined on a case-by-case basis, mostly based on providers'
        experiences or surgical request, because currently there is no clear clinical evidence behind
        that. With this clinical study, the investigators intend to build up clinical evidence by
        comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms:
        manual ventilation using AMBU bag arm and mechanical ventilation using a transport
        ventilator.
  
        Objective: In this study, the investigators plan to compare the effects of transport
        ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation,
        ventilation, biventricular function, and hemodynamics. This is a two-arm study.
  
          1. To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function,
             and hemodynamics (including blood pressure, heart rate, pulmonary artery pressure and
             central venous pressure) in the AMBU bag and Hamilton transport ventilator groups. The
             investigators hypothesize that using the Hamilton transport ventilator will show a
             smaller change in P/F ratio, hemodynamics, and biventricular function compared to the
             AMBU bag group. If true, these findings would support using the Hamilton ventilator for
             transport in appropriate surgical patients.
  
          2. To perform "in-vitro" flow analysis using a flow analyzer analyzer (CITREX H5:
  
        Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy
        of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different
        resistance and compliance settings of the lung simulator
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: After IRB approval and obtaining a written informed consent, patients will be randomly assigned to the one of the following 2 arms. However, AMBU bag arm patients may be switched to Hamilton C1 at an anesthesia provider's discretion based on post cardiopulmonary bypass right ventricular function, PaO2/FiO2, and PaCO2. These patients will be excluded from the AMBU bag arm.
  Arm 1: AMBU bag manual ventilation during transport to the ICU Arm 2: Hamilton C1 ventilator during transport to the ICU
  primary purpose: Diagnostic
  masking: Single (Participant)
  masking description: The patients will be randomly assigned to 2 arms above and the patients are not informed about which arm they are assigned.
  measure: The visual scale in changes in left ventricular function
  time frame: First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
  description: Within-group and between-group changes in visual assessment of left ventricular function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)
  measure: The visual scale in changes in right ventricular function
  time frame: First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
  description: Within-group and between-group changes in visual assessment of right ventricular cardiac function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)
  measure: The changes in PaO2/FiO2 (P/F ratio)
  time frame: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
  description: The changes in PaO2/FiO2 (P/F ratio) pre and post transport to ICU. P/F ratio will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above.
  measure: The changes in PaCO2
  time frame: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
  description: The changes in PaCO2 pre and post transport to ICU. PaCO2 will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above.
  arm group label: Arm 1: AMBU bag manual ventilation during transport to the ICU
  arm group type: No Intervention
  arm group label: Arm 2: Hamilton C1 ventilator during transport to the ICU
  arm group type: Experimental
  intervention type: Device
  intervention name: Hamilton C1 ventilator during transport to the ICU
  description: Instead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU
  arm group label: Arm 2: Hamilton C1 ventilator during transport to the ICU
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Thomas Jefferson University
  investigator full name: Yoshihisa Morita, MD
  investigator title: Associate professor