<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/NCT03032939</url>
  </required_header>
  <id_info>
    <org_study_id>PT071</org_study_id>
    <nct_id>NCT03032939</nct_id>
  </id_info>
  <brief_title>The Effect of Tracheal Intubation on AC and DC Components of a Photoplethysmograph</brief_title>
  <official_title>The Effect of Tracheal Intubation Induced Autonomic Response on Photoplethysmography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      Intraoperative stress responses (vasoconstriction and changes in heart rate) and&#xD;
      postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in&#xD;
      tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter&#xD;
      (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious&#xD;
      stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component&#xD;
      of PPG. The aim of this study was to investigate the effect of a known noxious stimulus&#xD;
      (endotracheal intubation) on both the AC and DC components of PPG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2007</start_date>
  <completion_date type="Actual">January 30, 2015</completion_date>
  <primary_completion_date type="Actual">January 30, 2012</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>Photoplethysmography</measure>
    <time_frame>within 60 seconds of intubation</time_frame>
    <description>changes in AC and DC components of photoplethysmography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulse rate</measure>
    <time_frame>within 60 seconds of intubation</time_frame>
    <description>Pulse rate from photoplethysmograph</description>
  </secondary_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Anesthesia Intubation Complication</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endotracheal intubation</intervention_name>
    <description>standard endotracheal intubation of surgical patients after induction of anesthesia</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elective, healthy surgical patients over 18 yrs of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  General endotracheal anesthesia&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vascular disease&#xD;
&#xD;
          -  Liver or kidney disease&#xD;
&#xD;
          -  Overweight&#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>Pekka O Talke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Pekka Talke</investigator_full_name>
    <investigator_title>Professor of Anesthesia</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>only a unique study number such as, IP01, that is unrelated to any patient identifiers will be used</ipd_description>
  </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/NCT03032939
org study id: PT071
nct id: NCT03032939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intraoperative stress responses (vasoconstriction and changes in heart rate) and
      postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in
      tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter
      (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious
      stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component
      of PPG. The aim of this study was to investigate the effect of a known noxious stimulus
      (endotracheal intubation) on both the AC and DC components of PPG.
observational model: Case-Only
time perspective: Prospective
measure: Photoplethysmography
time frame: within 60 seconds of intubation
description: changes in AC and DC components of photoplethysmography
measure: Pulse rate
time frame: within 60 seconds of intubation
description: Pulse rate from photoplethysmograph
intervention type: Procedure
intervention name: endotracheal intubation
description: standard endotracheal intubation of surgical patients after induction of anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pekka O Talke, MD
role: Principal Investigator
affiliation: University of California, San Francisco
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Pekka Talke
investigator title: Professor of Anesthesia
sharing ipd: No
ipd description: only a unique study number such as, IP01, that is unrelated to any patient identifiers will be used