<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/NCT03287687</url>
  </required_header>
  <id_info>
    <org_study_id>201706767</org_study_id>
    <nct_id>NCT03287687</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of CO2 for Endoscopy</brief_title>
  <official_title>The Safety and Efficacy of Carbon Dioxide for Insufflation During Endoscopy in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Warren Bishop</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal&#xD;
      distension and discomfort; it is equally effective as air in pediatric patients undergoing&#xD;
      endoscopic procedures.&#xD;
&#xD;
      Aim 1:&#xD;
&#xD;
      Determine the occurrence and severity of abdominal discomfort and distension associated with&#xD;
      endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4&#xD;
      hours after discharge in carbon dioxide group when compared to the air group.&#xD;
&#xD;
      Aim 2:&#xD;
&#xD;
      Determine if the expertise level of the endoscopist contributes to abdominal discomfort and&#xD;
      distension following endoscopy, and whether this differs in the carbon dioxide group versus&#xD;
      air group.&#xD;
&#xD;
      Aim 3:&#xD;
&#xD;
      Determine if carbon dioxide is as effective as air for insufflation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN: A Prospective, Randomized, Double-Blinded, Controlled Trial We intend to enroll&#xD;
      250 patients aged between 6 months and 21 years in a randomized, double-blind study comparing&#xD;
      the use of air (our current routine) vs. carbon dioxide (CO2) for insufflation (inflation) of&#xD;
      the gut during endoscopy. The primary endpoint will be abdominal girth and abdominal&#xD;
      pain/discomfort after undergoing the endoscopy. Secondary endpoints will be indirect measures&#xD;
      of CO2 absorption (respiratory rate and end-tidal CO2)throughout the procedure, determination&#xD;
      whether the endoscopist's training level influences the primary endpoint,and determination if&#xD;
      CO2 and air are equally effective for adequate intestinal visualization . Similar studies in&#xD;
      adults have demonstrated safety and efficacy of CO2 in minimizing bloating and abdominal pain&#xD;
      following endoscopy and show no difference in efficacy of insufflation. However, studies done&#xD;
      to date in children have not been comprehensive in data gathering and analysis. We now have&#xD;
      the capability to routinely use CO2 for insufflation in our new Stead Family Children's&#xD;
      Hospital procedure unit, and wish to take this opportunity to fully document both efficacy&#xD;
      and safety of CO2 insufflation in children undergoing our most common endoscopic procedures,&#xD;
      including esophagogastroduodenoscopy (EGD, upper endoscopy,) colonoscopy, or combined upper&#xD;
      endoscopy and colonoscopy. All patients in the study will be sedated by the anesthesia team&#xD;
      using propofol as the primary agent. We will exclude patients who are judged to be at risk of&#xD;
      respiratory compromise.&#xD;
&#xD;
      Informed consent will be obtained as always for the procedure itself; additional consent and/&#xD;
      assent (when appropriate) will be obtained for study participation. For patients or parents&#xD;
      who opt out of the study; air will be used, as per our current routine, for insufflation.&#xD;
      Those willing to participate in the study will be randomly assigned to either carbon dioxide&#xD;
      or air for insufflation during their endoscopic procedure. Both the endoscopist and patient&#xD;
      will be blinded to arm of study.&#xD;
&#xD;
      DATA COLLECTION: At baseline, routine vital signs (HR, BP, RR, oxygen saturation), end tidal&#xD;
      CO2, and pain assessment (see below) will be documented. Abdominal girth, measured at the&#xD;
      umbilicus, will be documented at baseline as well. The expertise level of the primary&#xD;
      endoscopist will be noted; fellow (1st, 2nd, or 3rd year) or faculty will be recorded. A&#xD;
      faculty gastroenterologist will be present for the entire procedure.&#xD;
&#xD;
      During the endoscopic procedure, again as per our usual routine, end-tidal CO2 will be&#xD;
      continuously monitored and recorded in Epic by the anesthesia team. Other parameters that&#xD;
      will be monitored and recorded continuously will include, HR, BP respiratory rate, and oxygen&#xD;
      saturation. Based on published studies, we do not anticipate any evidence of detectable CO2&#xD;
      absorption during the procedure, but will be prepared to unblind the study and switch to air&#xD;
      insufflation if any concern arises during the procedure. The duration and type of procedure&#xD;
      will be noted for all patients.&#xD;
&#xD;
      At the end of the procedure, Heart rate (HR) , Blood pressure (BP), respiratory rate (RR),&#xD;
      oxygen saturation, end tidal CO2, abdominal girth, and pain assessment will be documented&#xD;
      again. &quot;Breath to breath&quot; analysis of the end tidal CO2 monitor tracing will be performed&#xD;
      later, using recorded data, study by Dr. Timothy Starner (Pediatric pulmonologist). This will&#xD;
      enable us to determine if there had been any evidence of an increased respiratory rate&#xD;
      associated with increased CO2 absorption.&#xD;
&#xD;
      We will use the verbal scale : face, legs, activity, cry, consolability (FLACC) scale to&#xD;
      assess pain upon arrival to recovery area. After awakening, abdominal discomfort will be&#xD;
      assessed for children who are able to do so, and the assessment will be repeated at discharge&#xD;
      from the facility. FLACC will be used for all children with appropriate developmental status,&#xD;
      age 5 years and older for normal children. After discharge, the parents will complete an&#xD;
      additional brief pain assessment at home at 4 hours after discharge. For those who had an&#xD;
      abdominal girth increase of at least 10% from baseline, abdominal girth will be re-measured&#xD;
      at home, at 4 hours after discharge.&#xD;
&#xD;
      We will use the non-verbal FLACC scale for children unable to verbally report pain using the&#xD;
      visual scale.&#xD;
&#xD;
      Parents will report pain and abdominal girth data done at home by returning a pre-stamped&#xD;
      postcard. Those who do not communicate this information will be called by a member of the&#xD;
      research team for this information after five working days.&#xD;
&#xD;
      We hypothesize, based on adult and few pediatric studies, that post-procedure abdominal&#xD;
      discomfort will be significantly decreased in the CO2 group, and that CO2 will be shown to be&#xD;
      safe and effective for endoscopic insufflation.&#xD;
&#xD;
      Efficacy of insufflation will be assessed by the endoscopist immediately after the procedure&#xD;
      using a 5-point Likert scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">April 9, 2019</completion_date>
  <primary_completion_date type="Actual">April 9, 2019</primary_completion_date>
  <phase>Phase 4</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>Double blinded, placebo controlled study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomization will be done 1:1, double blinded. - Procedure nurse will randomly choose an envelope from a box; the envelope contains a card listing either &quot;CO2&quot; or &quot;Air&quot;. The envelopes will be unmarked and will be prepared with an equal number of cards for each arm. The procedure nurse then turns on either CO2 or air insufflation according to the card in the envelope. The air/CO2 controls will be kept covered to preserve blinding of the endoscopist. She will also record the patient's arm allocation in a logbook, which will be kept in a locked cabinet.&#xD;
These events will precede entry of the patient and endoscopist into the procedure room.&#xD;
Therefore, all study participants are blinded and allocation is also blinded also.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Abdominal Distension</measure>
    <time_frame>Mean change in abdominal girth between time points were compared between groups</time_frame>
    <description>Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Elevations of End Tidal Carbon Dioxide</measure>
    <time_frame>Time frame of monitoring from start to end of procedure (average of 12 minutes for EGD procedures)</time_frame>
    <description>Number of Procedures with Elevated End Tidal CO2 level (≥ 60 mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedures With Post Endoscopy Reported Symptoms</measure>
    <time_frame>Frequency of reported symptoms up to 4 hours post endoscopy was compared between groups</time_frame>
    <description>Procedures with post endoscopy reported symptoms, up to 4 hours, of belching, bloating and flatulence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Endoscopy</condition>
  <condition>Insufflation</condition>
  <arm_group>
    <arm_group_label>Air for insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbon dioxide gas for insufflation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbon dioxide (CO2) gas insufflation</intervention_name>
    <description>CO2 gas use for insufflation during endoscopy instead of air insufflation</description>
    <arm_group_label>Carbon dioxide gas for insufflation</arm_group_label>
    <other_name>CO2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Air insufflation</intervention_name>
    <description>Air insufflation is the standard of practice (used in the control arm)</description>
    <arm_group_label>Air for insufflation</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric gastroenterology patients aged 6 months through 21 years undergoing&#xD;
             endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2&#xD;
             procedure room or the operating room in the SFCH who willingly consent/ascent to the&#xD;
             study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and&#xD;
             those having both Esophagogastroduodenoscopy and Colonoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non English speaking families who require the services of a translator Children&#xD;
             outside the stipulated age range of study. Children in foster care homes or wards of&#xD;
             the court. Children and parents who do not willingly consent to the study Children&#xD;
             with history of bronchopulmonary dysplasia or other chronic respiratory compromise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Warren P Bishop, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Homan M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10.</citation>
    <PMID>26363332</PMID>
  </results_reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>August 17, 2021</results_first_submitted>
  <results_first_submitted_qc>January 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2022</results_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Warren Bishop</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03287687/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03287687/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>180 procedures were enrolled; 91 procedures in the CO2 group and 89 procedures in the air group.&#xD;
There were 178 participants enrolled. 2 participants were enrolled twice</recruitment_details>
      <pre_assignment_details>There were no significant events in this study. There were 178 patients enrolled for 180 procedures. 2 participants were enrolled twice</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Air for Insufflation</title>
          <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation&#xD;
Air: Air is the standard of practice and will be used in the control arm</description>
        </group>
        <group group_id="P2">
          <title>Carbon Dioxide Gas for Insufflation</title>
          <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy&#xD;
Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Procedures</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>178 participants enrolled in 180 procedures were blindly randomized to arms air or CO2 insufflation</population>
      <group_list>
        <group group_id="B1">
          <title>Air for Insufflation</title>
          <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation&#xD;
Air: Air is the standard of practice and will be used in the control arm</description>
        </group>
        <group group_id="B2">
          <title>Carbon Dioxide Gas for Insufflation</title>
          <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy&#xD;
Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
            <count group_id="B2" value="90"/>
            <count group_id="B3" value="178"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 4 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 4 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.2" lower_limit="7.9" upper_limit="97.4"/>
                    <measurement group_id="B2" value="46.6" lower_limit="9.4" upper_limit="128.5"/>
                    <measurement group_id="B3" value="46.9" lower_limit="7.9" upper_limit="128.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA class status</title>
          <description>Patient's overall health status based on American Society of Anesthesiologists (ASA) classification (ASA class I and II considered low risk sedation population, higher ASA class considered high risk population)</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Low ASA class (I&amp;II, low sedation risk)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High ASA class (&gt; II high sedation risk)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of procedure</title>
          <description>Patients undergoing diagnostic or therapeutic endoscopic procedures were recruited including esophagogastroduodenoscopy only (EGD), combined EGD and colonoscopy, percutaneous endoscopic gastrostomy PEG, and PEG tube exchange. Some participants were included in more than one procedure.</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>EGD only</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EGD/Colonoscopy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Colonoscopy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Abdominal Distension</title>
        <description>Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)</description>
        <time_frame>Mean change in abdominal girth between time points were compared between groups</time_frame>
        <population>178 participants were enrolled for 180 procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Air for Insufflation</title>
            <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation&#xD;
Air: Air is the standard of practice and will be used in the control arm</description>
          </group>
          <group group_id="O2">
            <title>Carbon Dioxide Gas for Insufflation</title>
            <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy&#xD;
Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Abdominal Distension</title>
          <description>Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)</description>
          <population>178 participants were enrolled for 180 procedures</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Procedures</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Procedures</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time Difference 1: Difference from baseline to end of procedure (median 16 minutes), cm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Procedures</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.3"/>
                    <measurement group_id="O2" value="0.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time Difference 2: Difference from baseline to discharge (approximately 120 minutes), cm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Procedures</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="2.2"/>
                    <measurement group_id="O2" value="0.9" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Elevations of End Tidal Carbon Dioxide</title>
        <description>Number of Procedures with Elevated End Tidal CO2 level (≥ 60 mmHg)</description>
        <time_frame>Time frame of monitoring from start to end of procedure (average of 12 minutes for EGD procedures)</time_frame>
        <population>178 participants were included in 180 procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Air for Insufflation</title>
            <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation&#xD;
Air: Air is the standard of practice and will be used in the control arm</description>
          </group>
          <group group_id="O2">
            <title>Carbon Dioxide Gas for Insufflation</title>
            <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy&#xD;
Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air</description>
          </group>
        </group_list>
        <measure>
          <title>Elevations of End Tidal Carbon Dioxide</title>
          <description>Number of Procedures with Elevated End Tidal CO2 level (≥ 60 mmHg)</description>
          <population>178 participants were included in 180 procedures</population>
          <units>Procedures</units>
          <param>Number</param>
          <units_analyzed>Procedures</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Procedures</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedures With Post Endoscopy Reported Symptoms</title>
        <description>Procedures with post endoscopy reported symptoms, up to 4 hours, of belching, bloating and flatulence</description>
        <time_frame>Frequency of reported symptoms up to 4 hours post endoscopy was compared between groups</time_frame>
        <population>178 participants were enrolled for 180 procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Air for Insufflation</title>
            <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation&#xD;
Air: Air is the standard of practice and will be used in the control arm</description>
          </group>
          <group group_id="O2">
            <title>Carbon Dioxide Gas for Insufflation</title>
            <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy&#xD;
Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air</description>
          </group>
        </group_list>
        <measure>
          <title>Procedures With Post Endoscopy Reported Symptoms</title>
          <description>Procedures with post endoscopy reported symptoms, up to 4 hours, of belching, bloating and flatulence</description>
          <population>178 participants were enrolled for 180 procedures</population>
          <units>procedures</units>
          <param>Number</param>
          <units_analyzed>Procedures</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Procedures</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Belching</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Procedures</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Procedures</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flatulence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Procedures</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from start of procedure time up to 4 hours post procedure</time_frame>
      <desc>All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration</desc>
      <group_list>
        <group group_id="E1">
          <title>Air for Insufflation</title>
          <description>In this arm of patients, air which is currently used as standard of care will be used for insufflation&#xD;
Air: Air is the standard of practice and will be used in the control arm</description>
        </group>
        <group group_id="E2">
          <title>Carbon Dioxide Gas for Insufflation</title>
          <description>in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy&#xD;
Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Procedural related complication - Bleeding</sub_title>
                <description>Bleeding</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anesthesia related complication - Aspiration</sub_title>
                <description>Aspiration</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Anesthesia related complication - Hypoxia</sub_title>
                <description>Hypoxia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Warren Bishop, Professor of Pediatrics</name_or_title>
      <organization>University of Iowa</organization>
      <phone>319 356 2977</phone>
      <email>warren-bishop@uiowa.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03287687
org study id: 201706767
nct id: NCT03287687
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Hypothesis:

      Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal
      distension and discomfort; it is equally effective as air in pediatric patients undergoing
      endoscopic procedures.

      Aim 1:

      Determine the occurrence and severity of abdominal discomfort and distension associated with
      endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4
      hours after discharge in carbon dioxide group when compared to the air group.

      Aim 2:

      Determine if the expertise level of the endoscopist contributes to abdominal discomfort and
      distension following endoscopy, and whether this differs in the carbon dioxide group versus
      air group.

      Aim 3:

      Determine if carbon dioxide is as effective as air for insufflation.
STUDY DESIGN: A Prospective, Randomized, Double-Blinded, Controlled Trial We intend to enroll
      250 patients aged between 6 months and 21 years in a randomized, double-blind study comparing
      the use of air (our current routine) vs. carbon dioxide (CO2) for insufflation (inflation) of
      the gut during endoscopy. The primary endpoint will be abdominal girth and abdominal
      pain/discomfort after undergoing the endoscopy. Secondary endpoints will be indirect measures
      of CO2 absorption (respiratory rate and end-tidal CO2)throughout the procedure, determination
      whether the endoscopist's training level influences the primary endpoint,and determination if
      CO2 and air are equally effective for adequate intestinal visualization . Similar studies in
      adults have demonstrated safety and efficacy of CO2 in minimizing bloating and abdominal pain
      following endoscopy and show no difference in efficacy of insufflation. However, studies done
      to date in children have not been comprehensive in data gathering and analysis. We now have
      the capability to routinely use CO2 for insufflation in our new Stead Family Children's
      Hospital procedure unit, and wish to take this opportunity to fully document both efficacy
      and safety of CO2 insufflation in children undergoing our most common endoscopic procedures,
      including esophagogastroduodenoscopy (EGD, upper endoscopy,) colonoscopy, or combined upper
      endoscopy and colonoscopy. All patients in the study will be sedated by the anesthesia team
      using propofol as the primary agent. We will exclude patients who are judged to be at risk of
      respiratory compromise.

      Informed consent will be obtained as always for the procedure itself; additional consent and/
      assent (when appropriate) will be obtained for study participation. For patients or parents
      who opt out of the study; air will be used, as per our current routine, for insufflation.
      Those willing to participate in the study will be randomly assigned to either carbon dioxide
      or air for insufflation during their endoscopic procedure. Both the endoscopist and patient
      will be blinded to arm of study.

      DATA COLLECTION: At baseline, routine vital signs (HR, BP, RR, oxygen saturation), end tidal
      CO2, and pain assessment (see below) will be documented. Abdominal girth, measured at the
      umbilicus, will be documented at baseline as well. The expertise level of the primary
      endoscopist will be noted; fellow (1st, 2nd, or 3rd year) or faculty will be recorded. A
      faculty gastroenterologist will be present for the entire procedure.

      During the endoscopic procedure, again as per our usual routine, end-tidal CO2 will be
      continuously monitored and recorded in Epic by the anesthesia team. Other parameters that
      will be monitored and recorded continuously will include, HR, BP respiratory rate, and oxygen
      saturation. Based on published studies, we do not anticipate any evidence of detectable CO2
      absorption during the procedure, but will be prepared to unblind the study and switch to air
      insufflation if any concern arises during the procedure. The duration and type of procedure
      will be noted for all patients.

      At the end of the procedure, Heart rate (HR) , Blood pressure (BP), respiratory rate (RR),
      oxygen saturation, end tidal CO2, abdominal girth, and pain assessment will be documented
      again. "Breath to breath" analysis of the end tidal CO2 monitor tracing will be performed
      later, using recorded data, study by Dr. Timothy Starner (Pediatric pulmonologist). This will
      enable us to determine if there had been any evidence of an increased respiratory rate
      associated with increased CO2 absorption.

      We will use the verbal scale : face, legs, activity, cry, consolability (FLACC) scale to
      assess pain upon arrival to recovery area. After awakening, abdominal discomfort will be
      assessed for children who are able to do so, and the assessment will be repeated at discharge
      from the facility. FLACC will be used for all children with appropriate developmental status,
      age 5 years and older for normal children. After discharge, the parents will complete an
      additional brief pain assessment at home at 4 hours after discharge. For those who had an
      abdominal girth increase of at least 10% from baseline, abdominal girth will be re-measured
      at home, at 4 hours after discharge.

      We will use the non-verbal FLACC scale for children unable to verbally report pain using the
      visual scale.

      Parents will report pain and abdominal girth data done at home by returning a pre-stamped
      postcard. Those who do not communicate this information will be called by a member of the
      research team for this information after five working days.

      We hypothesize, based on adult and few pediatric studies, that post-procedure abdominal
      discomfort will be significantly decreased in the CO2 group, and that CO2 will be shown to be
      safe and effective for endoscopic insufflation.

      Efficacy of insufflation will be assessed by the endoscopist immediately after the procedure
      using a 5-point Likert scale.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blinded, placebo controlled study
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomization will be done 1:1, double blinded. - Procedure nurse will randomly choose an envelope from a box; the envelope contains a card listing either "CO2" or "Air". The envelopes will be unmarked and will be prepared with an equal number of cards for each arm. The procedure nurse then turns on either CO2 or air insufflation according to the card in the envelope. The air/CO2 controls will be kept covered to preserve blinding of the endoscopist. She will also record the patient's arm allocation in a logbook, which will be kept in a locked cabinet.
These events will precede entry of the patient and endoscopist into the procedure room.
Therefore, all study participants are blinded and allocation is also blinded also.
measure: Change in Abdominal Distension
time frame: Mean change in abdominal girth between time points were compared between groups
description: Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)
measure: Elevations of End Tidal Carbon Dioxide
time frame: Time frame of monitoring from start to end of procedure (average of 12 minutes for EGD procedures)
description: Number of Procedures with Elevated End Tidal CO2 level (≥ 60 mmHg)
measure: Procedures With Post Endoscopy Reported Symptoms
time frame: Frequency of reported symptoms up to 4 hours post endoscopy was compared between groups
description: Procedures with post endoscopy reported symptoms, up to 4 hours, of belching, bloating and flatulence
arm group label: Air for insufflation
arm group type: Active Comparator
description: In this arm of patients, air which is currently used as standard of care will be used for insufflation
arm group label: Carbon dioxide gas for insufflation
arm group type: Experimental
description: in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy
intervention type: Drug
intervention name: Carbon dioxide (CO2) gas insufflation
description: CO2 gas use for insufflation during endoscopy instead of air insufflation
arm group label: Carbon dioxide gas for insufflation
other name: CO2
intervention type: Drug
intervention name: Air insufflation
description: Air insufflation is the standard of practice (used in the control arm)
arm group label: Air for insufflation
other name: Control
criteria: 
gender: All
minimum age: 6 Months
maximum age: 21 Years
healthy volunteers: No
last name: Warren P Bishop, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
citation: Homan M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10.
PMID: 26363332
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Warren Bishop
investigator title: Principal Investigator
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 