<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/NCT03294993</url>
  </required_header>
  <id_info>
    <org_study_id>20170711</org_study_id>
    <nct_id>NCT03294993</nct_id>
  </id_info>
  <brief_title>Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture</brief_title>
  <official_title>Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</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 investigators designed a study to assess whether there were any blood flow indexes change&#xD;
      before and after radial artery puncture with doppler ultrasonography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators designed a study to assess whether there were any blood flow indexes change&#xD;
      before and after radial artery puncture with doppler ultrasonography.The indexes include&#xD;
      Arterial Diameter,Peak Systolic Velocity,End Diastolic Velocity,Resistive Index,Pulsatility&#xD;
      Index,Systolic/End Diastolic Ratio,Time AverageMean Velocity and Blood Flow.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no participants enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change of Peak Systolic Velocity</measure>
    <time_frame>baseline and 30 minutes after surgery</time_frame>
    <description>The Change of Peak Systolic Velocity before and after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of modified Allen test</measure>
    <time_frame>baseline and 30 minutes after surgery</time_frame>
    <description>the change of modified Allen test before and after surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Blood Flow Indexes</condition>
  <arm_group>
    <arm_group_label>Ultrasound assess group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound assess</intervention_name>
    <description>The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography</description>
    <arm_group_label>Ultrasound assess group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were included in the study if they were ethnic Chinese, between 18 and 65&#xD;
             years old, American Society of Anesthesiologists (ASA) physical status I or&#xD;
             II,candidates for general anesthesia undergoing thoracic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they do not want to cooperate with the test, had a history&#xD;
             of upper extremity arteriosclerosis obliterans or thromboangitis obliterans,had a&#xD;
             history of radial artery puncture or coronary artery bypass grafting,had acute vessel&#xD;
             trauma,or had been diagnosed with Raynaud' disease,had suffered from mental or&#xD;
             neurological disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Ma, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>Associate proffesor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03294993
org study id: 20170711
nct id: NCT03294993
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators designed a study to assess whether there were any blood flow indexes change
      before and after radial artery puncture with doppler ultrasonography
The investigators designed a study to assess whether there were any blood flow indexes change
      before and after radial artery puncture with doppler ultrasonography.The indexes include
      Arterial Diameter,Peak Systolic Velocity,End Diastolic Velocity,Resistive Index,Pulsatility
      Index,Systolic/End Diastolic Ratio,Time AverageMean Velocity and Blood Flow.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture
primary purpose: Screening
masking: None (Open Label)
measure: The Change of Peak Systolic Velocity
time frame: baseline and 30 minutes after surgery
description: The Change of Peak Systolic Velocity before and after surgery
measure: the change of modified Allen test
time frame: baseline and 30 minutes after surgery
description: the change of modified Allen test before and after surgery
arm group label: Ultrasound assess group
arm group type: Experimental
description: The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography
intervention type: Device
intervention name: Ultrasound assess
description: The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography
arm group label: Ultrasound assess group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Ma, MD,PhD
role: Study Chair
affiliation: Department of Anesthesiology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: Associate proffesor
sharing ipd: Undecided