<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/NCT04490369</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00102686</org_study_id>
    <nct_id>NCT04490369</nct_id>
  </id_info>
  <brief_title>Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab</brief_title>
  <official_title>Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      The purpose of this study is to explore how the timing of procedural sedation medications&#xD;
      influences patient comfort and satisfaction with sedation.&#xD;
&#xD;
      Participation in this study will included be randomly assigned to one of two groups (long and&#xD;
      short) within standard of care. Each group will observe a time interval between receiving&#xD;
      procedural sedation medications and the start of the procedure. A trained observer will&#xD;
      evaluate patient experience during the procedure and at the end of the procedure we will ask&#xD;
      the participant 3 brief questions about the experience. All other information collected about&#xD;
      the experience during the procedure will occur as part of usual care. No further activities&#xD;
      will be asked as part of this study. All study activities will occur during a scheduled visit&#xD;
      and participation is complete once questions have been answered.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total medication administration dosage as measured by the procedural database</measure>
    <time_frame>During procedure, up to 2.5 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of medication administration as measured by the procedural database</measure>
    <time_frame>During procedure, up to 2.5 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)</measure>
    <time_frame>Within 2 hours of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)</measure>
    <time_frame>During procedure, to 2.5 hours</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">175</enrollment>
  <condition>Patient Comfort</condition>
  <arm_group>
    <arm_group_label>Group 1- short interval</arm_group_label>
    <description>Less than or equal to six minutes between receiving sedation and the start of the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2- long interval</arm_group_label>
    <description>Greater than or equal to seven minutes between receiving sedation and the start of the procedure</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients coming to Duke University for Cardiac Catheterization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Coming to Duke University for Cardiac Catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradi Granger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.</citation>
    <PMID>36640418</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Procedural sedation</keyword>
  <keyword>Cardiac Catheterization</keyword>
  <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/NCT04490369
org study id: Pro00102686
nct id: NCT04490369
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore how the timing of procedural sedation medications
      influences patient comfort and satisfaction with sedation.

      Participation in this study will included be randomly assigned to one of two groups (long and
      short) within standard of care. Each group will observe a time interval between receiving
      procedural sedation medications and the start of the procedure. A trained observer will
      evaluate patient experience during the procedure and at the end of the procedure we will ask
      the participant 3 brief questions about the experience. All other information collected about
      the experience during the procedure will occur as part of usual care. No further activities
      will be asked as part of this study. All study activities will occur during a scheduled visit
      and participation is complete once questions have been answered.
observational model: Cohort
time perspective: Prospective
measure: Total medication administration dosage as measured by the procedural database
time frame: During procedure, up to 2.5 hours
measure: Frequency of medication administration as measured by the procedural database
time frame: During procedure, up to 2.5 hours
measure: Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)
time frame: Within 2 hours of procedure
measure: Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)
time frame: During procedure, to 2.5 hours
arm group label: Group 1- short interval
description: Less than or equal to six minutes between receiving sedation and the start of the procedure
arm group label: Group 2- long interval
description: Greater than or equal to seven minutes between receiving sedation and the start of the procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bradi Granger, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
citation: Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.
PMID: 36640418
responsible party type: Sponsor
sharing ipd: No