<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/NCT03267017</url>
  </required_header>
  <id_info>
    <org_study_id>RRV PPV</org_study_id>
    <nct_id>NCT03267017</nct_id>
  </id_info>
  <brief_title>Correlation Between Respiratory Variability of R-R Intervals and Systolic Pressure Variability</brief_title>
  <official_title>Correlation Between Respiratory Variability of R-R Intervals and in Invasive Systolic Blood Pressure During Changes in Posture and Positive End Expiratory Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      This prospective study is designed to assess and quantify the correlation between respiratory&#xD;
      changes in R-R interval and the respiratory changed in invasive systolic blood pressure in&#xD;
      ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and&#xD;
      following a fluid bolus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 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>Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure</measure>
    <time_frame>From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Heart Rate Determination</condition>
  <arm_group>
    <arm_group_label>Patient scheduled for surgery under general anesthesia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>posture changes</intervention_name>
    <description>Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O</description>
    <arm_group_label>Patient scheduled for surgery under general anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Scheduled for surgery under general anesthesia requiring invasive blood pressure&#xD;
             monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart Rate other than sinus&#xD;
&#xD;
          -  Cardiac Pacemaker Status&#xD;
&#xD;
          -  Transplanted Heart&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Dr. Amit Lehavi MD FANZCA</investigator_full_name>
    <investigator_title>Director of Pediatric Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03267017
org study id: RRV PPV
nct id: NCT03267017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective study is designed to assess and quantify the correlation between respiratory
      changes in R-R interval and the respiratory changed in invasive systolic blood pressure in
      ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and
      following a fluid bolus
observational model: Cohort
time perspective: Prospective
measure: Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure
time frame: From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later
arm group label: Patient scheduled for surgery under general anesthesia
intervention type: Other
intervention name: posture changes
description: Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O
arm group label: Patient scheduled for surgery under general anesthesia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Dr. Amit Lehavi MD FANZCA
investigator title: Director of Pediatric Anesthesia
mesh term: Systolic Murmurs
sharing ipd: No