<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/NCT01733446</url>
  </required_header>
  <id_info>
    <org_study_id>816280</org_study_id>
    <nct_id>NCT01733446</nct_id>
  </id_info>
  <brief_title>A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration</brief_title>
  <acronym>RIP03</acronym>
  <official_title>A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration With Respiratory Inductance Plethysmography (RIP) During High Frequency Jet Ventilation (HFJV) Under General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators data reveal an important new observation regarding the recovery of&#xD;
      breathing during emergence from general anesthesia: respiration resumes as a prolonged&#xD;
      abdominal expiration event.&#xD;
&#xD;
      The present study aims to further clarify the physiology of recovery of breathing with the&#xD;
      addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of&#xD;
      two different recovery paradigms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study will use non-invasive respiratory inductance plethysmography(RIP) and&#xD;
      transcutaneous carbon dioxide measurement to compare recovery of respiration under constant&#xD;
      Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet&#xD;
      ventilation HFJV (study method) with recovery of respiration during rising and apnea (current&#xD;
      standard).&#xD;
&#xD;
      The investigators hypothesize that the prolonged abdominal expiration that we observed during&#xD;
      recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2)&#xD;
      levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>spontaneous breathing</measure>
    <time_frame>Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath</time_frame>
    <description>The primary variable will be first breath as detected by Respiratory Inductance Plethysmography (RIP. This will occur in the operating room at the end of the surgery and anesthesia.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Surgery</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Standard anesthesia regimen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Positive pressure ventilation will be stopped at the same time infusions of anesthetic agents and spontaneous ventilation employed until emergence from anesthesia is observed. (This is standard protocol for everyday anesthesia management of this population.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuation of High Frequency Jet Ventilation ( HFJV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Group B after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuation of High Frequency Jet Ventilation (HFJV)</intervention_name>
    <description>In Group B, after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and Transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.</description>
    <arm_group_label>Continuation of High Frequency Jet Ventilation ( HFJV)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female patients ages &gt; 18 to &lt; 80&#xD;
&#xD;
          2. Scheduled for procedures under general anesthesia with jet ventilation&#xD;
&#xD;
          3. Sign informed consent&#xD;
&#xD;
          4. Candidate for total intravenous anesthesia with propofol and remifentanil (which is&#xD;
             standard protocol in this type of population)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Absence of informed consent&#xD;
&#xD;
          2. No planned use intra-operative use of jet ventilation&#xD;
&#xD;
          3. Known difficulties with jet ventilation during prior surgical procedures&#xD;
&#xD;
          4. Emergency surgery&#xD;
&#xD;
          5. Baseline (oxygen saturation)SpO2 &lt;92% on room air&#xD;
&#xD;
          6. BMI &gt; 50&#xD;
&#xD;
          7. Pregnant or lactating females&#xD;
&#xD;
          8. Skin damage, rash or significant lesions in the areas covered by the RIP bands or&#xD;
             transcutaneous CO2 sensor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua H Atkins, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 20, 2018</last_update_submitted>
  <last_update_submitted_qc>April 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High frequency jet ventilation</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/NCT01733446
org study id: 816280
nct id: NCT01733446
lead sponsor: 
has dmc: Yes
The investigators data reveal an important new observation regarding the recovery of
      breathing during emergence from general anesthesia: respiration resumes as a prolonged
      abdominal expiration event.

      The present study aims to further clarify the physiology of recovery of breathing with the
      addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of
      two different recovery paradigms.
The present study will use non-invasive respiratory inductance plethysmography(RIP) and
      transcutaneous carbon dioxide measurement to compare recovery of respiration under constant
      Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet
      ventilation HFJV (study method) with recovery of respiration during rising and apnea (current
      standard).

      The investigators hypothesize that the prolonged abdominal expiration that we observed during
      recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2)
      levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: spontaneous breathing
time frame: Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath
description: The primary variable will be first breath as detected by Respiratory Inductance Plethysmography (RIP. This will occur in the operating room at the end of the surgery and anesthesia.)
arm group label: Standard anesthesia regimen
arm group type: No Intervention
description: Positive pressure ventilation will be stopped at the same time infusions of anesthetic agents and spontaneous ventilation employed until emergence from anesthesia is observed. (This is standard protocol for everyday anesthesia management of this population.)
arm group label: Continuation of High Frequency Jet Ventilation ( HFJV)
arm group type: Experimental
description: In Group B after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.
intervention type: Other
intervention name: Continuation of High Frequency Jet Ventilation (HFJV)
description: In Group B, after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and Transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.
arm group label: Continuation of High Frequency Jet Ventilation ( HFJV)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joshua H Atkins, MD PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor