<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/NCT03007355</url>
  </required_header>
  <id_info>
    <org_study_id>N 2015</org_study_id>
    <nct_id>NCT03007355</nct_id>
  </id_info>
  <brief_title>Peripheral Perfusion Index (PPI) as Monitor During Deliberate Hypotensive Anesthesia</brief_title>
  <acronym>PPI</acronym>
  <official_title>The Use of Peripheral Perfusion Index as a Predictor for Patient's Response to Deliberate Hypotension During Functional Endoscopic Sinus Surgery A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of&#xD;
      hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue&#xD;
      perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive&#xD;
      new monitoring, can reflect the peripheral perfusion dynamics.&#xD;
&#xD;
      This study is designed to explore the behaviour and trend of PPI during nitroglycerine&#xD;
      induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic&#xD;
      sinus surgery (FESS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>correlation between PPI and T1</measure>
    <time_frame>start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours</time_frame>
    <description>correlation of baseline values of PPI and time required to achieve target mean arterial pressure.</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Monitoring During Deliberate Hypotensive Anesthesia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>peripheral perfusion index measurement</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult male or females, aged between 18-50 years, ASA class I ans II&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, aged from 18-50 years, ASA physical status I and II, undergoing functional&#xD;
             endoscopic sinus surgery (FESS) under deliberate hypotensive anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic hypertension, cardiovascular disease, cerebrovascular&#xD;
             insufficiency, coagulation defects, renal or hepatic insufficiency, and&#xD;
             hypersensitivity to the study drugs will be excluded from the study. Patients&#xD;
             receiving vasoactive drugs or beta blockers will be also excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Abeer Ahmed, MD</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia - Faculty of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</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/NCT03007355
org study id: N 2015
nct id: NCT03007355
lead sponsor: 
has dmc: No
Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of
      hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue
      perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive
      new monitoring, can reflect the peripheral perfusion dynamics.

      This study is designed to explore the behaviour and trend of PPI during nitroglycerine
      induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic
      sinus surgery (FESS).
observational model: Other
time perspective: Prospective
measure: correlation between PPI and T1
time frame: start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours
description: correlation of baseline values of PPI and time required to achieve target mean arterial pressure.
intervention type: Other
intervention name: peripheral perfusion index measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Abeer Ahmed, MD
investigator title: Lecturer of Anesthesia - Faculty of Medicine
mesh term: Hypotension