<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/NCT03799588</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00002374</org_study_id>
    <nct_id>NCT03799588</nct_id>
  </id_info>
  <brief_title>Transmitted Lung Pressures With Biphasic Chest Cuirass</brief_title>
  <official_title>Transmitted Lung Pressure Values With Biphasic Chest Cuirass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</source>
  <oversight_info>
    <has_dmc>No</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>
      This study will examine the correlation between the transpulmonary pressure and the actual&#xD;
      setting on the biphasic chest cuirass device is the primary study end point.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional mechanical ventilation is known as positive pressure ventilation (PPV) because&#xD;
      the machine delivers positive pressure directly into the airways to ventilate and expand the&#xD;
      lungs. In a healthy lung, inflation occurs when the pressure inside the lung is greater than&#xD;
      the pressure outside the lung. This transpulmonary pressure is the difference between the&#xD;
      pressure inside the lung (in the alveolus) and the pressure just outside the lung (the&#xD;
      pleural cavity). Since positive pressure ventilation delivers pressure directly into the&#xD;
      airways, the transpulmonary pressure is increased by making the lung pressure more positive.&#xD;
      This is markedly different than physiologic breathing and carries an increased risk of&#xD;
      ventilator-associated lung injury1. In the setting of sick lungs, where the pressure required&#xD;
      to open collapsed areas of lung may be more than areas of healthy lung, this higher pressure&#xD;
      can in turn cause damage to the areas of healthy lung. The known effects of this&#xD;
      ventilator-associated lung injury from positive pressure ventilation can be avoided with the&#xD;
      use of negative pressure ventilation. In negative pressure ventilation (NPV), the&#xD;
      transpulmonary pressure is increased by making the pleural pressure more negative. This is&#xD;
      achieved by using a plastic shell that covers the chest and generates negative pressure&#xD;
      between the plastic shell and the chest. This pressure is distributed more evenly across a&#xD;
      large surface of the chest wall and results in more uniform lung expansion. As a result, NPV&#xD;
      results in better oxygen delivery and less lung injury than positive pressure ventilation2.&#xD;
&#xD;
      However, despite the extensive use of NPV in other countries, there is little data available&#xD;
      regarding the transpulmonary pressure that these machines can generate; i.e. how well does&#xD;
      negative pressure in the plastic shell transmit to the pleural cavity to expand the lung.&#xD;
      There is a large amount of data supporting the use of biphasic cuirass ventilation to&#xD;
      minimize lung damage3 and improve hemodynamics4-9, but no studies have been done to date that&#xD;
      look at the transpulmonary pressure and how it differs depending on age and size. It is still&#xD;
      unclear what optimal pressure is required via the chest cuirass to expand and ventilate the&#xD;
      lungs via. It is also unknown what maximum pressures can be used before the lung becomes&#xD;
      overinflated and complications arise.&#xD;
&#xD;
      This study will examine the correlation between the transpulmonary pressure and the actual&#xD;
      setting on the biphasic chest cuirass device is the primary study end point.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    personnel have left the facility&#xD;
  </why_stopped>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 31, 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>
    <intervention_model_description>After routine intubation for elective urologic procedures in the OR, the patient will be placed on a biphasic chest cuirass after anesthesia induction. A esophageal manometer will then be placed to measure transpulmonary pressures. The patient will be switched off the anesthesia ventilator and the biphasic chest cuirass will begin negative pressure ventilation. During this time, the patient will continue to receive inhalation anesthetic gas. After 30 minutes, the biphasic chest cuirass will terminate and the patient will again receive positive pressure ventilation via the anesthesia ventilator.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transpulmonary Pressure Deliverance</measure>
    <time_frame>1 year</time_frame>
    <description>Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>Biphasic Chest Cuirass Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biphasic Chest Cuirass</intervention_name>
    <description>Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.</description>
    <arm_group_label>Biphasic Chest Cuirass Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are between the age of 6 months and 5 years&#xD;
&#xD;
          2. Undergo circumcision, hypospadias repair, or orchidopexy in the operating room of the&#xD;
             John R. Oishei Children's Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of chronic lung disease or cyanotic heart disease or&#xD;
&#xD;
          2. Patients with significant chest wall abnormalities or other abnormalities that&#xD;
             preclude proper placement of the biphasic chest cuirass.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bree C Kramer, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oishei Children's Hospital</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Scholz SE, Knothe C, Thiel A, Hempelmann G. Improved oxygen delivery by positive pressure ventilation with continuous negative external chest pressure. Lancet. 1997 May 3;349(9061):1295-6. doi: 10.1016/S0140-6736(05)62507-X. No abstract available.</citation>
    <PMID>9142069</PMID>
  </reference>
  <reference>
    <citation>Petros AJ, Fernando SS, Shenoy VS, al-Saady NM. The Hayek oscillator. Nomograms for tidal volume and minute ventilation using external high frequency oscillation. Anaesthesia. 1995 Jul;50(7):601-6. doi: 10.1111/j.1365-2044.1995.tb15112.x.</citation>
    <PMID>7653758</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Bree Cyrene Kramer</investigator_full_name>
    <investigator_title>Assistant Clinical Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Pediatrics</keyword>
  <keyword>biphasic chest cuirass</keyword>
  <keyword>transpulmonary pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03799588
org study id: STUDY00002374
nct id: NCT03799588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the correlation between the transpulmonary pressure and the actual
      setting on the biphasic chest cuirass device is the primary study end point.
Conventional mechanical ventilation is known as positive pressure ventilation (PPV) because
      the machine delivers positive pressure directly into the airways to ventilate and expand the
      lungs. In a healthy lung, inflation occurs when the pressure inside the lung is greater than
      the pressure outside the lung. This transpulmonary pressure is the difference between the
      pressure inside the lung (in the alveolus) and the pressure just outside the lung (the
      pleural cavity). Since positive pressure ventilation delivers pressure directly into the
      airways, the transpulmonary pressure is increased by making the lung pressure more positive.
      This is markedly different than physiologic breathing and carries an increased risk of
      ventilator-associated lung injury1. In the setting of sick lungs, where the pressure required
      to open collapsed areas of lung may be more than areas of healthy lung, this higher pressure
      can in turn cause damage to the areas of healthy lung. The known effects of this
      ventilator-associated lung injury from positive pressure ventilation can be avoided with the
      use of negative pressure ventilation. In negative pressure ventilation (NPV), the
      transpulmonary pressure is increased by making the pleural pressure more negative. This is
      achieved by using a plastic shell that covers the chest and generates negative pressure
      between the plastic shell and the chest. This pressure is distributed more evenly across a
      large surface of the chest wall and results in more uniform lung expansion. As a result, NPV
      results in better oxygen delivery and less lung injury than positive pressure ventilation2.

      However, despite the extensive use of NPV in other countries, there is little data available
      regarding the transpulmonary pressure that these machines can generate; i.e. how well does
      negative pressure in the plastic shell transmit to the pleural cavity to expand the lung.
      There is a large amount of data supporting the use of biphasic cuirass ventilation to
      minimize lung damage3 and improve hemodynamics4-9, but no studies have been done to date that
      look at the transpulmonary pressure and how it differs depending on age and size. It is still
      unclear what optimal pressure is required via the chest cuirass to expand and ventilate the
      lungs via. It is also unknown what maximum pressures can be used before the lung becomes
      overinflated and complications arise.

      This study will examine the correlation between the transpulmonary pressure and the actual
      setting on the biphasic chest cuirass device is the primary study end point.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: After routine intubation for elective urologic procedures in the OR, the patient will be placed on a biphasic chest cuirass after anesthesia induction. A esophageal manometer will then be placed to measure transpulmonary pressures. The patient will be switched off the anesthesia ventilator and the biphasic chest cuirass will begin negative pressure ventilation. During this time, the patient will continue to receive inhalation anesthetic gas. After 30 minutes, the biphasic chest cuirass will terminate and the patient will again receive positive pressure ventilation via the anesthesia ventilator.
primary purpose: Other
masking: None (Open Label)
measure: Transpulmonary Pressure Deliverance
time frame: 1 year
description: Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
arm group label: Biphasic Chest Cuirass Arm
arm group type: Experimental
description: This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass.
intervention type: Device
intervention name: Biphasic Chest Cuirass
description: Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.
arm group label: Biphasic Chest Cuirass Arm
criteria: 
gender: Male
minimum age: 6 Months
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bree C Kramer, DO
role: Principal Investigator
affiliation: University at Buffalo
facility: 
country: United States
citation: Scholz SE, Knothe C, Thiel A, Hempelmann G. Improved oxygen delivery by positive pressure ventilation with continuous negative external chest pressure. Lancet. 1997 May 3;349(9061):1295-6. doi: 10.1016/S0140-6736(05)62507-X. No abstract available.
PMID: 9142069
citation: Petros AJ, Fernando SS, Shenoy VS, al-Saady NM. The Hayek oscillator. Nomograms for tidal volume and minute ventilation using external high frequency oscillation. Anaesthesia. 1995 Jul;50(7):601-6. doi: 10.1111/j.1365-2044.1995.tb15112.x.
PMID: 7653758
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Bree Cyrene Kramer
investigator title: Assistant Clinical Professor of Pediatrics
mesh term: Lung Diseases
sharing ipd: No