<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/NCT03754946</url>
  </required_header>
  <id_info>
    <org_study_id>201502019</org_study_id>
    <nct_id>NCT03754946</nct_id>
  </id_info>
  <brief_title>The Critical Threshold of Pulse Oximetry Plethysmographic Waveform Parameters in High Quality CPR</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the relationship of the area under the curve (AUC)&#xD;
      and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial&#xD;
      pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in&#xD;
      cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP&#xD;
      parameters in high quality CPR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>the cut-off value of POP parameters in High Quality CPR</measure>
    <time_frame>one year</time_frame>
    <description>Describe the the cut-off value of POP parameters in High Quality CPR. Receiver operating curve analysis was performed to evaluate the accuracy in predicting return of spontaneous circulation (ROSC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare different predictors</measure>
    <time_frame>one year</time_frame>
    <description>Area under curve (AUC) between potential predictors was compared by using a nonparametric test, and the optimal cutoff point was determined by estimating the Youden's index.</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cardiopulmonary Resuscitation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were admitted to the participant hospitals and met the inclusion criteria were&#xD;
        included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrested&#xD;
&#xD;
          -  The time from cardiac arrest to receiving basic life support is less than 10 minutes&#xD;
&#xD;
          -  Get advanced life support (endotracheal intubation and PETCO2 monitoring)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Defuse CPR&#xD;
&#xD;
          -  chronic obstructive pulmonary disease (COPD) with type II respiratory failure&#xD;
&#xD;
          -  Terminal malignant tumors or terminal stage of other diseases&#xD;
&#xD;
          -  Rib fracture&#xD;
&#xD;
          -  Cardiac arrest caused by hemorrhagic shock pulmonary embolism and cardiac tamponade&#xD;
&#xD;
          -  Sever anemia(HGB&lt;7g/dl)&#xD;
&#xD;
          -  Untreated tension pneumothorax&#xD;
&#xD;
          -  Tinea unguium, dyeing Fingernails and other factors affect the monitor of Pulse&#xD;
             Oximetry Plethysmographic Waveform such vasculitis and Raynaud's phenomenon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xuezhong Yu, MD</last_name>
    <phone>+86 010 69159142</phone>
    <email>yxzpumch@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Xu, M.D.</last_name>
      <phone>15801578819</phone>
      <email>xujunfree@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Feng Sun, M.D.</last_name>
      <phone>18120102816</phone>
      <email>sunfeng2016@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiopulmonary resuscitation</keyword>
  <keyword>pulse oximetry plethysmographic waveform</keyword>
  <keyword>quality monitor</keyword>
  <keyword>partial pressure of end-tidal carbon dioxide</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/NCT03754946
org study id: 201502019
nct id: NCT03754946
lead sponsor: 
The purpose of this study is to analyze the relationship of the area under the curve (AUC)
      and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial
      pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in
      cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP
      parameters in high quality CPR.
observational model: Cohort
time perspective: Prospective
measure: the cut-off value of POP parameters in High Quality CPR
time frame: one year
description: Describe the the cut-off value of POP parameters in High Quality CPR. Receiver operating curve analysis was performed to evaluate the accuracy in predicting return of spontaneous circulation (ROSC).
measure: Compare different predictors
time frame: one year
description: Area under curve (AUC) between potential predictors was compared by using a nonparametric test, and the optimal cutoff point was determined by estimating the Youden's index.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xuezhong Yu, MD
phone: +86 010 69159142
email: yxzpumch@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor