<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/NCT01677234</url>
  </required_header>
  <id_info>
    <org_study_id>H12-01797</org_study_id>
    <nct_id>NCT01677234</nct_id>
  </id_info>
  <brief_title>Wrist NIBP During Elective Cesarean Delivery</brief_title>
  <official_title>Comparison of Arm and Forearm Blood Pressure During Elective Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blood pressure is typically measured with a non-invasive cuff placed on the upper arm. This&#xD;
      cuff cannot take accurate measurements when the patient's arm is moving. Anesthesia for a&#xD;
      cesarean delivery frequently causes the patient to shiver and their arm to shake, and&#xD;
      sometimes to the extent that blood pressure cannot be measured. A cuff placed on the wrist&#xD;
      may be more effective when a patient is shivering because their lower arm moves less and can&#xD;
      be more easily stabilized. We will be taking simultaneous blood pressure measurements both&#xD;
      just before and during cesarean deliveries in order to compare blood pressure at the upper&#xD;
      arm versus the wrist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upper arm non-invasive blood pressure (NIBP) measurement is the most commonly accepted method&#xD;
      of blood pressure (BP) monitoring. During a cesarean delivery it may be challenging to obtain&#xD;
      an accurate measurement from the automated devices in over 50% of the attempts due to arm&#xD;
      movement.1 Patients may voluntarily move their arm, but more often neuraxial (spinal,&#xD;
      epidural, combined spinal-epidural) anesthesia is known to induce shivering that causes the&#xD;
      patient's arm to shake.2 To eliminate the effect of movement of the upper arm, NIBP has been&#xD;
      tested on the leg because it is immobilized during neuraxial anesthesia. However, studies&#xD;
      monitoring NIBP on an ankle or a calf were unable to accurately detect changes (increase or&#xD;
      decrease) in blood pressure in patients undergoing a cesarean delivery.3,4 It seems&#xD;
      clinically reasonable that in the case of a shivering patient, the forearm, with less muscle&#xD;
      mass, would shake less and could be stabilized more easily than the upper arm (stabilizing&#xD;
      the forearm is easily done by holding the patient's hand with a light pressure on the arm&#xD;
      rest). Therefore, positioning an NIBP cuff on the forearm (near the wrist) may be useful to&#xD;
      obtain an accurate blood pressure measurement in shivering patients.&#xD;
&#xD;
      Previous studies have found that forearm BP overestimates blood pressure measured at the&#xD;
      upper arm in a variety of clinical settings and patient populations under static (patient at&#xD;
      rest, not submitted to an intervention that might alter BP) circumstances.5-8 It is unknown&#xD;
      whether this overestimation is clinically relevant when blood pressure change occurs rapidly,&#xD;
      such as during a cesarean delivery. During neuraxial anesthesia for cesarean delivery, it is&#xD;
      important for the anesthesiologist to know both absolute values and clinically significant&#xD;
      changes in blood pressure to determine their treatment. The detection of dynamic changes in&#xD;
      blood pressure (as when the patient is submitted to an intervention that might alter BP per&#xD;
      se, e.g. neuraxial anesthesia) has been studied in obstetric patients. Nevertheless, either&#xD;
      due to the location where the BP cuff was placed4 (as on the lower limb with interference of&#xD;
      the aorto-caval compression) or to the technology used to measure blood pressure,9 (the penaz&#xD;
      technology was not consistent with oscillometric technology in a previous study) the forearm&#xD;
      blood pressure was not comparable to upper arm blood pressure when measured using an&#xD;
      oscillometric monitor.&#xD;
&#xD;
      This study will compare the upper arm (the current gold-standard) and the forearm NIBP&#xD;
      measurements in patients undergoing an elective cesarean delivery under subarachnoid&#xD;
      anesthesia. We hypothesize that the forearm systolic BP measurement values will be within 10%&#xD;
      (lower or higher) of the systolic BP values measured in the upper arm at the same time-points&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Compare trends in NIBP measurements between the upper arm and forearm</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measure NIBP at the upper arm and forearm simultaneously during surgery. NIBP cuffs will be on opposite arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To estimate the accuracy of blood pressure measured on the forearm</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Wrist Blood Pressure Measurements</condition>
  <condition>Anesthesia Resulting in Shivering</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant women undergoing a cesarean section</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women having an elective cesarean delivery at BC Women's Hospital in Vancouver, British&#xD;
        Columbia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy (American Society of Anesthesiologist's (ASA) physical status I or II)&#xD;
             patients&#xD;
&#xD;
          -  Having an elective cesarean delivery under spinal or combined spinal epidural&#xD;
             anesthesia&#xD;
&#xD;
          -  ≥19 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra-indication to neuraxial anesthesia&#xD;
&#xD;
          -  General anesthesia for any reason prior to delivery of the baby&#xD;
&#xD;
          -  Use of the epidural component (epidural top-up) of combined spinal epidural anesthesia&#xD;
             (prior to delivery of the baby)&#xD;
&#xD;
          -  History of cardiovascular disease, e.g. hypertension (either essential or&#xD;
             pregnancy-induced)&#xD;
&#xD;
          -  A difference of more than 10% between both upper arms and forearms in mean blood&#xD;
             pressure measurement prior to surgery (see below)&#xD;
&#xD;
          -  BMI &gt;35kg/m2 (it is more difficult to ensure the cuff size is correct in these obese&#xD;
             patients)&#xD;
&#xD;
          -  Inability to read and understand English for the purpose of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Massey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia, BC Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>British Columbia's Women's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>July 2, 2013</last_update_submitted>
  <last_update_submitted_qc>July 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood pressure</keyword>
  <pending_results>
    <submitted>April 27, 2017</submitted>
    <returned>August 9, 2017</returned>
    <submitted>August 11, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>September 5, 2017</submitted>
    <returned>April 11, 2018</returned>
  </pending_results>
  <!-- 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/NCT01677234
org study id: H12-01797
nct id: NCT01677234
lead sponsor: 
has dmc: No
Blood pressure is typically measured with a non-invasive cuff placed on the upper arm. This
      cuff cannot take accurate measurements when the patient's arm is moving. Anesthesia for a
      cesarean delivery frequently causes the patient to shiver and their arm to shake, and
      sometimes to the extent that blood pressure cannot be measured. A cuff placed on the wrist
      may be more effective when a patient is shivering because their lower arm moves less and can
      be more easily stabilized. We will be taking simultaneous blood pressure measurements both
      just before and during cesarean deliveries in order to compare blood pressure at the upper
      arm versus the wrist.
Upper arm non-invasive blood pressure (NIBP) measurement is the most commonly accepted method
      of blood pressure (BP) monitoring. During a cesarean delivery it may be challenging to obtain
      an accurate measurement from the automated devices in over 50% of the attempts due to arm
      movement.1 Patients may voluntarily move their arm, but more often neuraxial (spinal,
      epidural, combined spinal-epidural) anesthesia is known to induce shivering that causes the
      patient's arm to shake.2 To eliminate the effect of movement of the upper arm, NIBP has been
      tested on the leg because it is immobilized during neuraxial anesthesia. However, studies
      monitoring NIBP on an ankle or a calf were unable to accurately detect changes (increase or
      decrease) in blood pressure in patients undergoing a cesarean delivery.3,4 It seems
      clinically reasonable that in the case of a shivering patient, the forearm, with less muscle
      mass, would shake less and could be stabilized more easily than the upper arm (stabilizing
      the forearm is easily done by holding the patient's hand with a light pressure on the arm
      rest). Therefore, positioning an NIBP cuff on the forearm (near the wrist) may be useful to
      obtain an accurate blood pressure measurement in shivering patients.

      Previous studies have found that forearm BP overestimates blood pressure measured at the
      upper arm in a variety of clinical settings and patient populations under static (patient at
      rest, not submitted to an intervention that might alter BP) circumstances.5-8 It is unknown
      whether this overestimation is clinically relevant when blood pressure change occurs rapidly,
      such as during a cesarean delivery. During neuraxial anesthesia for cesarean delivery, it is
      important for the anesthesiologist to know both absolute values and clinically significant
      changes in blood pressure to determine their treatment. The detection of dynamic changes in
      blood pressure (as when the patient is submitted to an intervention that might alter BP per
      se, e.g. neuraxial anesthesia) has been studied in obstetric patients. Nevertheless, either
      due to the location where the BP cuff was placed4 (as on the lower limb with interference of
      the aorto-caval compression) or to the technology used to measure blood pressure,9 (the penaz
      technology was not consistent with oscillometric technology in a previous study) the forearm
      blood pressure was not comparable to upper arm blood pressure when measured using an
      oscillometric monitor.

      This study will compare the upper arm (the current gold-standard) and the forearm NIBP
      measurements in patients undergoing an elective cesarean delivery under subarachnoid
      anesthesia. We hypothesize that the forearm systolic BP measurement values will be within 10%
      (lower or higher) of the systolic BP values measured in the upper arm at the same time-points
observational model: Cohort
time perspective: Prospective
measure: Compare trends in NIBP measurements between the upper arm and forearm
time frame: 30 minutes
description: Measure NIBP at the upper arm and forearm simultaneously during surgery. NIBP cuffs will be on opposite arms.
measure: To estimate the accuracy of blood pressure measured on the forearm
time frame: 30 minutes
arm group label: Pregnant women
description: Pregnant women undergoing a cesarean section
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Massey, MD
role: Principal Investigator
affiliation: University of British Columbia, BC Women's Hospital
facility: 
country: Canada
responsible party type: Sponsor
submitted: April 27, 2017
returned: August 9, 2017
submitted: August 11, 2017
submission canceled: Unknown
submitted: September 5, 2017
returned: April 11, 2018