<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/NCT03827369</url>
  </required_header>
  <id_info>
    <org_study_id>TYGH107041</org_study_id>
    <nct_id>NCT03827369</nct_id>
  </id_info>
  <brief_title>The Blood Pressure Analysis on Critically Ill Patients</brief_title>
  <official_title>The Blood Pressure Analysis on Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taoyuan General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taoyuan General Hospital</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>
      The study is to explore the relationship between coefficient of variation of harmonic&#xD;
      magnitude (HCV) and different organ failures among those critically ill patients. In the&#xD;
      future, we can act as a warning system on patients with multiple organ failures or terminal&#xD;
      illness, also as an indicator of treatment effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Coefficient of variation of harmonic magnitude</measure>
    <time_frame>15 min</time_frame>
    <description>We measure the blood pressure of participants with multiple organ failures (MOF) by pressure transducer during the 6 months study in the ICU of Taoyuan General Hospital. The radial artery pressure pulse of both hands are recorded with a pressure transducer fixed on the skin with tape and an adjustable belt with a small button to achieve suitable pressure.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Multiple Organ Failure</condition>
  <condition>Intensive Care Unit Syndrome</condition>
  <arm_group>
    <arm_group_label>ICU patient</arm_group_label>
    <description>Pulse pressure of the radical artery was obtained by arterial line. The output of the transducer was connected to an IBM PC for analysis via an A/D converter with sampling rate = 250 datapoints/sec. The pulse spectrum was analyzed with the Fourier transformation using T (period) = 1 pulse time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ICU patient</intervention_name>
    <description>Our study is to measure the coefficient of variation of the HCV of the radial arterial pulse among ICU patients with multiple organ failures (MOF). Patients admitted to Taoyuan General Hospital were recorded during the 6 months study.</description>
    <arm_group_label>ICU patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients without severe arrhythmia admitted to the ICU of Taoyuan General Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU patients in the 20-to-99 age range&#xD;
&#xD;
          -  Subjects agree to sign the Informed Consent Form and are willing to cooperate with&#xD;
             Arterial pulse measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has severe arrhythmia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tzu-Yi Chuang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taoyuan General Hospital, Minstry of Healthy and Welfare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tzu-Yi Chuang</last_name>
    <phone>886-3-3699721</phone>
    <phone_ext>3787</phone_ext>
    <email>revival_chuang@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taoyuan General Hospital, Ministry of Health and Welfare</name>
      <address>
        <city>Taoyuan</city>
        <zip>33004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood pressure</keyword>
  <keyword>Arterial pulse</keyword>
  <keyword>Coefficient of variation of harmonic magnitude</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Organ Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT03827369
org study id: TYGH107041
nct id: NCT03827369
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to explore the relationship between coefficient of variation of harmonic
      magnitude (HCV) and different organ failures among those critically ill patients. In the
      future, we can act as a warning system on patients with multiple organ failures or terminal
      illness, also as an indicator of treatment effect.
observational model: Case-Only
time perspective: Prospective
measure: Coefficient of variation of harmonic magnitude
time frame: 15 min
description: We measure the blood pressure of participants with multiple organ failures (MOF) by pressure transducer during the 6 months study in the ICU of Taoyuan General Hospital. The radial artery pressure pulse of both hands are recorded with a pressure transducer fixed on the skin with tape and an adjustable belt with a small button to achieve suitable pressure.
arm group label: ICU patient
description: Pulse pressure of the radical artery was obtained by arterial line. The output of the transducer was connected to an IBM PC for analysis via an A/D converter with sampling rate = 250 datapoints/sec. The pulse spectrum was analyzed with the Fourier transformation using T (period) = 1 pulse time.
intervention type: Diagnostic Test
intervention name: ICU patient
description: Our study is to measure the coefficient of variation of the HCV of the radial arterial pulse among ICU patients with multiple organ failures (MOF). Patients admitted to Taoyuan General Hospital were recorded during the 6 months study.
arm group label: ICU patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Tzu-Yi Chuang
role: Principal Investigator
affiliation: Taoyuan General Hospital, Minstry of Healthy and Welfare
last name: Tzu-Yi Chuang
phone: 886-3-3699721
phone ext: 3787
email: revival_chuang@yahoo.com
facility: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Multiple Organ Failure