<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/NCT04469751</url>
  </required_header>
  <id_info>
    <org_study_id>2020-511</org_study_id>
    <nct_id>NCT04469751</nct_id>
  </id_info>
  <brief_title>Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients</brief_title>
  <official_title>Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients A Self-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>General Hospital of Ningxia Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anesthesiologists need to understand the specific difference between dorsalis pedis&#xD;
      arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood&#xD;
      pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is&#xD;
      significantly higher than that in RA, with little difference of diastolic blood pressure and&#xD;
      mean artery pressure in two sites. However, there is no specific study on the difference&#xD;
      between them, and it is not clear how the diagnosis and treatment threshold should be&#xD;
      adjusted when relying on DPA blood pressure measurement to guide treatment. The&#xD;
      intraoperative blood pressure of patients is in the normal range in most cases. The purpose&#xD;
      of this study is to analyze the correlation of different blood pressure stratification&#xD;
      (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the&#xD;
      correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical&#xD;
      decision-making and hemodynamic management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DPA-RA invasive blood pressure</measure>
    <time_frame>During anesthesia induction</time_frame>
    <description>All DPA-RA blood pressure dates are Separate analyzed in the following three intervals: Group1 (RASBP 90-109mmHg), Group1 (RASBP 110-129mmHg), Group1 (RASBP 130-149mmHg).The correlation and consistency of each group were analyzed</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>patients undergoing neurosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>invasive blood pressure monitoring</intervention_name>
    <description>radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia</description>
    <arm_group_label>patients undergoing neurosurgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent neurosurgery,American Society of Anesthesiologists' physical&#xD;
             status 1-3, BMI 18-24 kg/m², a clinical need for invasive arterial pressure monitoring&#xD;
             in the supine position.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Arterial puncture site injury or infection,heart failure, severe arrhythmia,&#xD;
             congenital heart disease, hypertension, diabetes,preoperative use of dehydration, and&#xD;
             intracranial hypertension drugs such as mannitol, peripheral and macrovascular&#xD;
             diseases, chronic lung disease, history of heart or lung surgery, The Allens test was&#xD;
             positive.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chen Y, Cui J, Sun JJ, Wang E, Zhu Y, Li Y, Lu K. Gradient between dorsalis pedis and radial arterial blood pressures during sevoflurane anaesthesia: A self-control study in patients undergoing neurosurgery. Eur J Anaesthesiol. 2016 Feb;33(2):110-7. doi: 10.1097/EJA.0000000000000295.</citation>
    <PMID>26694940</PMID>
  </reference>
  <reference>
    <citation>Chen Y, Wang E, Zhu Y, Li Y, Lu K. Dorsalis pedis arterial pressure is lower than noninvasive arm blood pressure in normotensive patients under sevoflurane anesthesia. Blood Press Monit. 2016 Feb;21(1):27-32. doi: 10.1097/MBP.0000000000000153.</citation>
    <PMID>26484744</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>correlation radial artery dorsalis pedis artery</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/NCT04469751
org study id: 2020-511
nct id: NCT04469751
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Anesthesiologists need to understand the specific difference between dorsalis pedis
      arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood
      pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is
      significantly higher than that in RA, with little difference of diastolic blood pressure and
      mean artery pressure in two sites. However, there is no specific study on the difference
      between them, and it is not clear how the diagnosis and treatment threshold should be
      adjusted when relying on DPA blood pressure measurement to guide treatment. The
      intraoperative blood pressure of patients is in the normal range in most cases. The purpose
      of this study is to analyze the correlation of different blood pressure stratification
      (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the
      correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical
      decision-making and hemodynamic management.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: DPA-RA invasive blood pressure
time frame: During anesthesia induction
description: All DPA-RA blood pressure dates are Separate analyzed in the following three intervals: Group1 (RASBP 90-109mmHg), Group1 (RASBP 110-129mmHg), Group1 (RASBP 130-149mmHg).The correlation and consistency of each group were analyzed
arm group label: patients undergoing neurosurgery
arm group type: Experimental
description: radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia
intervention type: Diagnostic Test
intervention name: invasive blood pressure monitoring
description: radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia
arm group label: patients undergoing neurosurgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
citation: Chen Y, Cui J, Sun JJ, Wang E, Zhu Y, Li Y, Lu K. Gradient between dorsalis pedis and radial arterial blood pressures during sevoflurane anaesthesia: A self-control study in patients undergoing neurosurgery. Eur J Anaesthesiol. 2016 Feb;33(2):110-7. doi: 10.1097/EJA.0000000000000295.
PMID: 26694940
citation: Chen Y, Wang E, Zhu Y, Li Y, Lu K. Dorsalis pedis arterial pressure is lower than noninvasive arm blood pressure in normotensive patients under sevoflurane anesthesia. Blood Press Monit. 2016 Feb;21(1):27-32. doi: 10.1097/MBP.0000000000000153.
PMID: 26484744
responsible party type: Sponsor