<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/NCT01698853</url>
  </required_header>
  <id_info>
    <org_study_id>192837</org_study_id>
    <nct_id>NCT01698853</nct_id>
  </id_info>
  <brief_title>Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy</brief_title>
  <official_title>The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally&#xD;
      thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ&#xD;
      hypoperfusion.&#xD;
&#xD;
      Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde&#xD;
      perfusion. However,whether the arterial oxygenation status from different parts of the body&#xD;
      are the same in the condition of retrograde perfusion have not been studied.&#xD;
&#xD;
      The present study is aimed to determine if there is difference in the arterial oxygenation&#xD;
      between peripheral arterial and aortic root during the period of retrograde perfusion.In&#xD;
      addition, the impact of artificial ventilation on the difference of arterial oxygenation will&#xD;
      also be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients included will be assigned into two different groups according to the surgical&#xD;
      approach,one group is named &quot;NP&quot; with normal perfusion,and the other is named &quot;RP&quot; with&#xD;
      retrograde perfusion.&#xD;
&#xD;
      For all the patients,we will obtain 0.5ml blood from both peripheral arterial and aortic root&#xD;
      for blood gas analysis at some specific time points.&#xD;
&#xD;
      We will focus on the differences of arterial oxygenation between peripheral arterial and&#xD;
      aortic root at each group.At the same time,we will analyse the impact of artificial&#xD;
      ventilation on it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The difference between peripheral arterial oxygenation and aortic root blood oxygenation</measure>
    <time_frame>patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION</time_frame>
    <description>The three time points for blood sample collection are:1.right before clamping the aorta; 2.Three minutes after **** without ventilation;3.5 min after re-initiate mechanical ventilation.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bypass Complications</condition>
  <condition>Disorder of Blood Gas</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years old&#xD;
&#xD;
          -  undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  without informed consent&#xD;
&#xD;
          -  pregnancy&#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>Hailong Dong, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>department director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Chen, M.D.</last_name>
    <phone>86-13991221157</phone>
    <email>chenminh@yahoo.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jing Zhao, M.D.</last_name>
    <phone>86-13892810471</phone>
    <email>zhaojing939699@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Anesthesiology, Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Min Chen, M.D.</last_name>
      <phone>86-13991221157</phone>
      <email>chenminh@yahoo.com.cn</email>
    </contact>
    <contact_backup>
      <last_name>Jing Zhao, M.D.</last_name>
      <phone>86-13892810471</phone>
      <email>zhaojing939699@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Hailong Dong, M.D., PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 29, 2012</last_update_submitted>
  <last_update_submitted_qc>September 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01698853
org study id: 192837
nct id: NCT01698853
lead sponsor: 
has dmc: No
Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally
      thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ
      hypoperfusion.

      Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde
      perfusion. However,whether the arterial oxygenation status from different parts of the body
      are the same in the condition of retrograde perfusion have not been studied.

      The present study is aimed to determine if there is difference in the arterial oxygenation
      between peripheral arterial and aortic root during the period of retrograde perfusion.In
      addition, the impact of artificial ventilation on the difference of arterial oxygenation will
      also be investigated.
All patients included will be assigned into two different groups according to the surgical
      approach,one group is named "NP" with normal perfusion,and the other is named "RP" with
      retrograde perfusion.

      For all the patients,we will obtain 0.5ml blood from both peripheral arterial and aortic root
      for blood gas analysis at some specific time points.

      We will focus on the differences of arterial oxygenation between peripheral arterial and
      aortic root at each group.At the same time,we will analyse the impact of artificial
      ventilation on it.
time perspective: Prospective
measure: The difference between peripheral arterial oxygenation and aortic root blood oxygenation
time frame: patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION
description: The three time points for blood sample collection are:1.right before clamping the aorta; 2.Three minutes after **** without ventilation;3.5 min after re-initiate mechanical ventilation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hailong Dong, Doctor
role: Study Chair
affiliation: department director
last name: Min Chen, M.D.
phone: 86-13991221157
email: chenminh@yahoo.com.cn
last name: Jing Zhao, M.D.
phone: 86-13892810471
email: zhaojing939699@126.com
facility: 
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor