<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/NCT03755271</url>
  </required_header>
  <id_info>
    <org_study_id>1/2018/PO</org_study_id>
    <nct_id>NCT03755271</nct_id>
  </id_info>
  <brief_title>Hemodynamic Monitoring in Obstetrics</brief_title>
  <official_title>Hemodynamic Monitoring in Obstetrics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Catania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marinella Astuto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carmelo Minardi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mirko Mineri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Francesco Vasile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gaetano Joseph Palumbo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Catania</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>
      Spinal anesthesia has long been considered the first choice technique in caesarean section,&#xD;
      but although it is a reliable and safe procedure, it is in some cases associated with&#xD;
      undesirable effects. Maternal hypotension after sub-arachnoid anesthesia is a reduction in&#xD;
      systolic blood pressure below 100 mmHg or a decrease of 20% compared to baseline values.&#xD;
      According to some authors, maternal hypotension occurs up to 80% in women undergoing&#xD;
      caesarean section after spinal anesthesia. In order to reduce the incidence of maternal&#xD;
      hypotension, some measures can be taken:&#xD;
&#xD;
        -  a reduction of aorto-caval compression by manual displacement of the uterus on the left;&#xD;
&#xD;
        -  hemodynamic monitoring;&#xD;
&#xD;
        -  administration of fluids;&#xD;
&#xD;
        -  optimization of the dosage of the local anesthetic;&#xD;
&#xD;
        -  use of vasopressors.&#xD;
&#xD;
      The main objective of the study is to investigate, through the use of a continuous&#xD;
      non-invasive hemodynamic monitoring system (Clearsight® - Edwards Lifesciences), the&#xD;
      incidence of hypotension in pregnant women at risk undergoing spinal anesthesia due to&#xD;
      elective cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective observational not-for profit study, 128 patients will be enrolled to&#xD;
      measure the incidence of hypotension during spinal anesthesia for elective cesarean section.&#xD;
      On the occasion of the preoperative visit, all patients to be subjected to elective cesarean&#xD;
      section will be subjected to the Postural Change Test (PCT), a predictive test for maternal&#xD;
      hypotension during spinal anesthesia that evaluate changes in heart rate of pregnant women&#xD;
      following postural changes. Specifically, after monitoring the heart rate in the supine&#xD;
      position, the patient is asked to change decubitus (from supine to left lateral and then back&#xD;
      to supine). The test is positive if the patient's heart rate changes more than 10% from&#xD;
      baseline.&#xD;
&#xD;
      Once arrived in the obstetric emergency department, parturients with positive Postural Change&#xD;
      Test will be subjected to cannulation of a peripheral vein through a 18-20 Gauge needle&#xD;
      cannula and the Clearsight hemodynamic monitoring system will be placed on a finger. The&#xD;
      investigators will then proceed to the detection of the following parameters:&#xD;
&#xD;
        -  Mean Blood Pressure (MAP);&#xD;
&#xD;
        -  Heart Rate (HR);&#xD;
&#xD;
        -  Stroke volume (SV);&#xD;
&#xD;
        -  Stroke volume Index (SVI);&#xD;
&#xD;
        -  Cardiac Index (CI). These data will be collected and reported in the data sheet of the&#xD;
           study, at different time points (T0 - T9). Basal values will be collected at T0 and T1:&#xD;
           at T0 when the patient is in the supine position and at T1 when the patient is in a&#xD;
           lateral position. The investigators will then proceed to the administration of a&#xD;
           crystalloid bolus (10 ml/kg) and to the execution of spinal anesthesia (T2). The spinal&#xD;
           block needle will be inserted, compatibly to the patient's anatomical conditions, at the&#xD;
           L3-L4 / L4-L5 spaces. 0.5% hyperbaric Bupivacaine (5 mg/ml) will be administered at a&#xD;
           dose depending on the patient's weight and height.&#xD;
&#xD;
      Once the spinal block has been performed, the patient will be immediately placed in a supine&#xD;
      position. The investigators will then continue monitoring the parameters listed above using&#xD;
      Clearsight® (SV, SVI, MAP, CI) at 2-minute intervals in the phases following spinal&#xD;
      anesthesia:&#xD;
&#xD;
        -  T3: 2 minutes after spinal anesthesia,&#xD;
&#xD;
        -  T4: 4 minutes after spinal anesthesia,&#xD;
&#xD;
        -  T5: 6 minutes after spinal anesthesia,&#xD;
&#xD;
        -  T6: 8 minutes after spinal anesthesia. The other measurements will be made at skin&#xD;
           incision (T7), uterine incision (T8) and extraction (T9).&#xD;
&#xD;
      Any hemodynamic changes (MAP &lt;60 mmHg or CI &lt;2.5), under volemic optimization conditions,&#xD;
      will be treated by administration of vasoconstrictors (Etilefrine, intravenous bolus of 1-3&#xD;
      mg).&#xD;
&#xD;
      At the afterbirth, the investigators will proceed to the infusion of liquids and uterotonic&#xD;
      according regimens in use at the unit of Anesthesia and Intensive Care of the Universitary&#xD;
      Hospital &quot;G. Rodolico&quot; of Catania.&#xD;
&#xD;
      Given the descriptive nature of the study, a formal calculation of the sample size was not&#xD;
      made. As secondary end-points, the Stroke Volume variation following spinal anesthesia, the&#xD;
      amount of fluids administered, the vasoconstrictor doses used, diuresis, the Apgar index and&#xD;
      the fetal pH will be measured. The number of hypotension episodes not detected by the&#xD;
      traditional blood pressure monitoring system but detected by the Clearsight system will also&#xD;
      be recorded. For the qualitative variables, the absolute frequencies and the percentage&#xD;
      frequencies will be calculated. For the quantitative variables, if with normal distribution,&#xD;
      mean and standard deviation will be calculated; if with not normal distribution, median and&#xD;
      interquartile range will be calculated.&#xD;
&#xD;
      The normality of the distribution will be evaluated through the Kolmogorov-Smirnoff test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2018</start_date>
  <completion_date type="Actual">July 20, 2018</completion_date>
  <primary_completion_date type="Actual">July 20, 2018</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>Incidence of hypotension assessed through the use of the non-invasive hemodynamic monitoring system ClearSight</measure>
    <time_frame>Intraoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>2 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>4 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>6 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>8 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>2 minutes after cutaneous incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>2 minutes after uterine incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume (SV) from basal</measure>
    <time_frame>2 minutes after extraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>2 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>4 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>6 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>8 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>2 minutes after cutaneous incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>2 minutes after uterine incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Stroke Volume Index (SVI) from basal</measure>
    <time_frame>2 minutes after extraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>2 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>4 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>6 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>8 minutes after spinal anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>2 minutes after cutaneous incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>2 minutes after uterine incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modifications of Cardiac Index (CI) from basal</measure>
    <time_frame>2 minutes after extraction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for inotropes and / or vasopressor during surgery</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Doses of inotropes and / or vasopressor administered during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for fluids administration during surgery</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Volume of fluids administered during surgery for the eventual treatment of hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of urine excreted during surgery</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of fetal health through Apgar score</measure>
    <time_frame>At 1 and at 5 minute after birth</time_frame>
    <description>The Apgar score is determined by evaluating the newborn baby on five simple criteria (skin color, pulse rate, reflex irritability grimace, activity and respiratory effort) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The test is done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypotension episodes not detected by the traditional pressure cuff but detected by the Clearsight system</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">148</enrollment>
  <condition>Hypotension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        148 pregnant women, at risk of developing hypotension, undergoing spinal anesthesia for&#xD;
        elective Caesarean section at the Universitary Hospital &quot;G. Rodolico&quot; of Catania&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 40 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Classification I-II&#xD;
&#xD;
          -  Positive Postural Change Test (PCT)&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years or above 40 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Classification III-V&#xD;
&#xD;
          -  Negative Postural Change Test (PCT)&#xD;
&#xD;
          -  Refusal by the parturients to sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo Murabito, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Catania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marinella Astuto, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Catania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>&quot;G. Rodolico&quot; Presidium of the Azienda Ospedaliero Universitaria &quot;Policlinico-Vittorio Emanuele&quot;</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Catania</investigator_affiliation>
    <investigator_full_name>Paolo Murabito</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Intraoperative hypotension</keyword>
  <keyword>Caesarean section</keyword>
  <keyword>Spinal anesthesia</keyword>
  <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/NCT03755271
org study id: 1/2018/PO
nct id: NCT03755271
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spinal anesthesia has long been considered the first choice technique in caesarean section,
      but although it is a reliable and safe procedure, it is in some cases associated with
      undesirable effects. Maternal hypotension after sub-arachnoid anesthesia is a reduction in
      systolic blood pressure below 100 mmHg or a decrease of 20% compared to baseline values.
      According to some authors, maternal hypotension occurs up to 80% in women undergoing
      caesarean section after spinal anesthesia. In order to reduce the incidence of maternal
      hypotension, some measures can be taken:

        -  a reduction of aorto-caval compression by manual displacement of the uterus on the left;

        -  hemodynamic monitoring;

        -  administration of fluids;

        -  optimization of the dosage of the local anesthetic;

        -  use of vasopressors.

      The main objective of the study is to investigate, through the use of a continuous
      non-invasive hemodynamic monitoring system (Clearsight® - Edwards Lifesciences), the
      incidence of hypotension in pregnant women at risk undergoing spinal anesthesia due to
      elective cesarean section.
In this prospective observational not-for profit study, 128 patients will be enrolled to
      measure the incidence of hypotension during spinal anesthesia for elective cesarean section.
      On the occasion of the preoperative visit, all patients to be subjected to elective cesarean
      section will be subjected to the Postural Change Test (PCT), a predictive test for maternal
      hypotension during spinal anesthesia that evaluate changes in heart rate of pregnant women
      following postural changes. Specifically, after monitoring the heart rate in the supine
      position, the patient is asked to change decubitus (from supine to left lateral and then back
      to supine). The test is positive if the patient's heart rate changes more than 10% from
      baseline.

      Once arrived in the obstetric emergency department, parturients with positive Postural Change
      Test will be subjected to cannulation of a peripheral vein through a 18-20 Gauge needle
      cannula and the Clearsight hemodynamic monitoring system will be placed on a finger. The
      investigators will then proceed to the detection of the following parameters:

        -  Mean Blood Pressure (MAP);

        -  Heart Rate (HR);

        -  Stroke volume (SV);

        -  Stroke volume Index (SVI);

        -  Cardiac Index (CI). These data will be collected and reported in the data sheet of the
           study, at different time points (T0 - T9). Basal values will be collected at T0 and T1:
           at T0 when the patient is in the supine position and at T1 when the patient is in a
           lateral position. The investigators will then proceed to the administration of a
           crystalloid bolus (10 ml/kg) and to the execution of spinal anesthesia (T2). The spinal
           block needle will be inserted, compatibly to the patient's anatomical conditions, at the
           L3-L4 / L4-L5 spaces. 0.5% hyperbaric Bupivacaine (5 mg/ml) will be administered at a
           dose depending on the patient's weight and height.

      Once the spinal block has been performed, the patient will be immediately placed in a supine
      position. The investigators will then continue monitoring the parameters listed above using
      Clearsight® (SV, SVI, MAP, CI) at 2-minute intervals in the phases following spinal
      anesthesia:

        -  T3: 2 minutes after spinal anesthesia,

        -  T4: 4 minutes after spinal anesthesia,

        -  T5: 6 minutes after spinal anesthesia,

        -  T6: 8 minutes after spinal anesthesia. The other measurements will be made at skin
           incision (T7), uterine incision (T8) and extraction (T9).

      Any hemodynamic changes (MAP <60 mmHg or CI <2.5), under volemic optimization conditions,
      will be treated by administration of vasoconstrictors (Etilefrine, intravenous bolus of 1-3
      mg).

      At the afterbirth, the investigators will proceed to the infusion of liquids and uterotonic
      according regimens in use at the unit of Anesthesia and Intensive Care of the Universitary
      Hospital "G. Rodolico" of Catania.

      Given the descriptive nature of the study, a formal calculation of the sample size was not
      made. As secondary end-points, the Stroke Volume variation following spinal anesthesia, the
      amount of fluids administered, the vasoconstrictor doses used, diuresis, the Apgar index and
      the fetal pH will be measured. The number of hypotension episodes not detected by the
      traditional blood pressure monitoring system but detected by the Clearsight system will also
      be recorded. For the qualitative variables, the absolute frequencies and the percentage
      frequencies will be calculated. For the quantitative variables, if with normal distribution,
      mean and standard deviation will be calculated; if with not normal distribution, median and
      interquartile range will be calculated.

      The normality of the distribution will be evaluated through the Kolmogorov-Smirnoff test.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of hypotension assessed through the use of the non-invasive hemodynamic monitoring system ClearSight
time frame: Intraoperatively
measure: Modifications of Stroke Volume (SV) from basal
time frame: 2 minutes after spinal anesthesia
measure: Modifications of Stroke Volume (SV) from basal
time frame: 4 minutes after spinal anesthesia
measure: Modifications of Stroke Volume (SV) from basal
time frame: 6 minutes after spinal anesthesia
measure: Modifications of Stroke Volume (SV) from basal
time frame: 8 minutes after spinal anesthesia
measure: Modifications of Stroke Volume (SV) from basal
time frame: 2 minutes after cutaneous incision
measure: Modifications of Stroke Volume (SV) from basal
time frame: 2 minutes after uterine incision
measure: Modifications of Stroke Volume (SV) from basal
time frame: 2 minutes after extraction
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 2 minutes after spinal anesthesia
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 4 minutes after spinal anesthesia
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 6 minutes after spinal anesthesia
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 8 minutes after spinal anesthesia
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 2 minutes after cutaneous incision
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 2 minutes after uterine incision
measure: Modifications of Stroke Volume Index (SVI) from basal
time frame: 2 minutes after extraction
measure: Modifications of Cardiac Index (CI) from basal
time frame: 2 minutes after spinal anesthesia
measure: Modifications of Cardiac Index (CI) from basal
time frame: 4 minutes after spinal anesthesia
measure: Modifications of Cardiac Index (CI) from basal
time frame: 6 minutes after spinal anesthesia
measure: Modifications of Cardiac Index (CI) from basal
time frame: 8 minutes after spinal anesthesia
measure: Modifications of Cardiac Index (CI) from basal
time frame: 2 minutes after cutaneous incision
measure: Modifications of Cardiac Index (CI) from basal
time frame: 2 minutes after uterine incision
measure: Modifications of Cardiac Index (CI) from basal
time frame: 2 minutes after extraction
measure: Need for inotropes and / or vasopressor during surgery
time frame: Intraoperatively
description: Doses of inotropes and / or vasopressor administered during surgery
measure: Need for fluids administration during surgery
time frame: Intraoperatively
description: Volume of fluids administered during surgery for the eventual treatment of hypotension
measure: Volume of urine excreted during surgery
time frame: Intraoperatively
measure: Evaluation of fetal health through Apgar score
time frame: At 1 and at 5 minute after birth
description: The Apgar score is determined by evaluating the newborn baby on five simple criteria (skin color, pulse rate, reflex irritability grimace, activity and respiratory effort) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The test is done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
measure: Number of hypotension episodes not detected by the traditional pressure cuff but detected by the Clearsight system
time frame: Intraoperatively
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Paolo Murabito, MD
role: Principal Investigator
affiliation: University of Catania
last name: Marinella Astuto, MD
role: Study Director
affiliation: University of Catania
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Catania
investigator full name: Paolo Murabito
investigator title: Assistant Professor
mesh term: Hypotension