<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/NCT03239847</url>
  </required_header>
  <id_info>
    <org_study_id>160877</org_study_id>
    <nct_id>NCT03239847</nct_id>
  </id_info>
  <brief_title>Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring</brief_title>
  <official_title>Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</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 aims to compare the time difference between radial arterial line placement and use&#xD;
      of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs.&#xD;
      use of a radial arterial line based on device and operating room costs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2016</start_date>
  <completion_date type="Actual">April 5, 2017</completion_date>
  <primary_completion_date type="Actual">April 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Anesthesia team will not be made aware of the purpose of the trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total Cost</measure>
    <time_frame>Patient time in operating room (approximately 2 hours)</time_frame>
    <description>Total cost of each approach, as defined by the sum of material (device) costs plus the value of operative room time per minute.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in preparation time between the two approaches</measure>
    <time_frame>From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates between the two groups.</measure>
    <time_frame>Patient time in operating room (approximately 2 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associated anticipated costs of complications between the two groups.</measure>
    <time_frame>Patient time in operating room (approximately 2 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction as assessed by post-operative questionnaire</measure>
    <time_frame>Questionnaire is assessed post-operatively at one day and at the 2-4 week follow up (approximately 5 minutes to assess)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesiologist satisfaction as assessed by post-operative questionnaire</measure>
    <time_frame>Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.</measure>
    <time_frame>Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity analysis to evaluated variation in times for arterial line placement</measure>
    <time_frame>From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity analysis to evaluated variable operating room time costs</measure>
    <time_frame>Patient time in operating room (approximately 2 hours)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cerebrovascular Disorders</condition>
  <arm_group>
    <arm_group_label>EndoPhys Sheath and Radial Arterial Line</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EndoPhys Sheath</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of patients will only receive the EndoPhys sheath during surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EndoPhys Sheath and Radial Arterial Line</intervention_name>
    <arm_group_label>EndoPhys Sheath and Radial Arterial Line</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EndoPhys Sheath</intervention_name>
    <arm_group_label>EndoPhys Sheath</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All elective neuro endovascular procedures requiring general anesthesia and continuous&#xD;
             invasive blood pressure monitoring&#xD;
&#xD;
          -  Adequate access to both the radial or femoral artery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-operative identification of contra-indication for radial arterial line placement&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Need for continued post-operative invasive blood pressure monitoring&#xD;
&#xD;
          -  Failure to obtain informed consent&#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>Michael T Froehler, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Michael Froehler</investigator_full_name>
    <investigator_title>Asst. Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</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/NCT03239847
org study id: 160877
nct id: NCT03239847
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the time difference between radial arterial line placement and use
      of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs.
      use of a radial arterial line based on device and operating room costs.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
masking description: Anesthesia team will not be made aware of the purpose of the trial.
measure: Total Cost
time frame: Patient time in operating room (approximately 2 hours)
description: Total cost of each approach, as defined by the sum of material (device) costs plus the value of operative room time per minute.
measure: Difference in preparation time between the two approaches
time frame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
measure: Complication rates between the two groups.
time frame: Patient time in operating room (approximately 2 hours)
measure: Associated anticipated costs of complications between the two groups.
time frame: Patient time in operating room (approximately 2 hours)
measure: Patient satisfaction as assessed by post-operative questionnaire
time frame: Questionnaire is assessed post-operatively at one day and at the 2-4 week follow up (approximately 5 minutes to assess)
measure: Anesthesiologist satisfaction as assessed by post-operative questionnaire
time frame: Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)
measure: Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.
time frame: Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours)
measure: Sensitivity analysis to evaluated variation in times for arterial line placement
time frame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
measure: Sensitivity analysis to evaluated variable operating room time costs
time frame: Patient time in operating room (approximately 2 hours)
arm group label: EndoPhys Sheath and Radial Arterial Line
arm group type: Experimental
description: This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.
arm group label: EndoPhys Sheath
arm group type: Experimental
description: This group of patients will only receive the EndoPhys sheath during surgery.
intervention type: Other
intervention name: EndoPhys Sheath and Radial Arterial Line
arm group label: EndoPhys Sheath and Radial Arterial Line
intervention type: Other
intervention name: EndoPhys Sheath
arm group label: EndoPhys Sheath
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael T Froehler, MD, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Michael Froehler
investigator title: Asst. Professor
mesh term: Cerebrovascular Disorders
sharing ipd: No