xml: <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/NCT06032169</url>
    </required_header>
    <id_info>
      <org_study_id>RC23_0233</org_study_id>
      <nct_id>NCT06032169</nct_id>
    </id_info>
    <brief_title>Ankle Measurements of Arterial Pressure: Semi-recumbent or Horizontal Position.</brief_title>
    <acronym>2PAC</acronym>
    <official_title>NON-INVASIVE MEASUREMENT OF ARTERIAL PRESSURE AT THE ANKLE: IMPACT OF POSITION, SEMI-RECUMBENT OR HORIZONTAL. A SINGLE-CENTER PROSPECTIVE STUDY.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nantes University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nantes University Hospital</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>
        The upper arm is sometimes inaccessible for arterial pressure (AP) measurement. Placing the&#xD;
        automatic cuff at the ankle is a common alternative. However, whether AP measurement at the&#xD;
        ankle is reliable is uncertain. Furthermore, it is unknown whether it is necessary to place&#xD;
        the patient in a horizontal position to improve the reliability of the measurement, or if&#xD;
        leaving the patient in default position (often semi-recumbent) is acceptable. The aim of this&#xD;
        study is to answer these questions. Additionally, investigators will evaluate whether a&#xD;
        smartphone application that allows for the simple measurement of AP (by gently placing a&#xD;
        finger on the camera lens) is a valuable alternative to upper arm measurements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A question that arises relatively frequently is &quot;when the upper arm is inaccessible, where&#xD;
        should the investigators place the automatic cuff to measure AP?&quot;. Indeed, surgical&#xD;
        intervention involving the upper limb, a wound, a fracture, or vascular access (temporary&#xD;
        catheter or arteriovenous fistula) often makes the arm unsuitable for monitoring AP with an&#xD;
        automatic cuff. The arterial catheter is not devoid of risks (including the loss of precious&#xD;
        time for its insertion) and is rarely an appropriate alternative, at least in the first&#xD;
        instance. Thus, the inaccessibility of the upper arm legitimates the frequent placement of&#xD;
        the automatic cuff at the ankle. However, the automatic cuff has only been validated for&#xD;
        placement at the upper arm, not at the ankle. Surprisingly, the reliability of ankle AP&#xD;
        measurements obtained by this positioning of the cuff at the ankle has been little studied:&#xD;
        only two studies, using arterial catheter as the reference method, are available, one of&#xD;
        which was in the specific population of patients with obesity. These studies reported that&#xD;
        the measurement error at the ankle was excessive, but confirmation is necessary.&#xD;
  &#xD;
        Patients, especially in acute care settings, are rarely in a strictly horizontal supine&#xD;
        position. For various reasons, the critically ill patient is rather in a semi-recumbent&#xD;
        position, meaning that the angle between the trunk and the horizontal axis is between 30 and&#xD;
        60°. Thus, the cuff placed at the ankle is no longer at the level of the heart and more&#xD;
        precisely of the phlebostatic axis. This could modify the hydrostatic pressure and lead to&#xD;
        overestimation of AP compared to a measurement of AP at heart level (on the arm or&#xD;
        invasively, for example). Indeed, the impact on AP measurement of the height of the upper arm&#xD;
        relative to the heart has already been demonstrated: the vertical displacement of the upper&#xD;
        arm changes the measured AP value. Does the angle of elevation of the trunk significantly&#xD;
        modify the AP measured at the ankle? If so, and since the measurement at the ankle in the&#xD;
        horizontal supine position (0°) tends to underestimate AP, do the different sources of&#xD;
        measurement error &quot;cancel out&quot; in the semi-recumbent position? In what position of the trunk&#xD;
        is it preferable to measure AP at the ankle? The answers to these questions are uncertain.&#xD;
        Indeed, the only study that investigators are aware of (a pilot study) and that specifically&#xD;
        addressed this issue did not provide clear answers. This is important since AP is a crucial&#xD;
        parameter of monitoring and therefore of therapeutic decision-making. It is remarkable that&#xD;
        in acute care settings, little to no attention is paid to trunk elevation when measuring BP&#xD;
        at the ankle, and of course, there is no automation of patient positioning (e.g., in a&#xD;
        horizontal position) prior to each automatic measurement at the ankle.&#xD;
  &#xD;
        Therefore, it appears important to evaluate the accuracy and precision of non-invasive ankle&#xD;
        measurements of AP and the impact of patient position on it. This will be the main objective&#xD;
        of the study. If these ankle measurements prove to be neither accurate nor precise, having an&#xD;
        alternative would be desirable. It is noteworthy that when the arm is inaccessible, the&#xD;
        finger often is. AP measurement at the finger is now possible with a simple smartphone. This&#xD;
        finger measurement requires calibration with one or two automatic cuff measurements, which&#xD;
        should be possible in most cases (the arm is frequently inaccessible for prolonged AP&#xD;
        monitoring, but still allows for one or two isolated measurements). So, which is the better&#xD;
        alternative site for AP measurement, the finger or ankle? AP measurement using a smartphone&#xD;
        has never been evaluated from this perspective. This will be a secondary objective of the&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate whether the non-invasive measurement error of ankle mean Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal).</measure>
      <time_frame>15 minutes</time_frame>
      <description>The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.&#xD;
  The reference AP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate whether the non-invasive measurement error of ankle systolic and diastolic Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal).</measure>
      <time_frame>15 minutes</time_frame>
      <description>The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate whether the non-invasive measurement error of mean, systolic and diastolic Arterial Pressure at the upper arm is acceptable in either patient position (semi-recumbent or horizontal).</measure>
      <time_frame>15 minutes</time_frame>
      <description>The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate whether the non-invasive measurement error of mean, systolic and diastolic Arterial Pressure with a smartphone is acceptable.</measure>
      <time_frame>15 minutes</time_frame>
      <description>The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the risk associated with measurement errors of systolic and mean Arterial Pressure with each technique at each position.</measure>
      <time_frame>15 minutes</time_frame>
      <description>Via a dedicated error grid, the risk associated with measurement errors was classified into one of the 5 risk levels ranging from &quot;no risk&quot; to &quot;dangerous risk&quot;. Distribution across the different risk levels was compared by Fisher exact tests.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the ability of noninvasive measurements to detect hypo-/hypertension.</measure>
      <time_frame>15 minutes</time_frame>
      <description>The ability of averaged noninvasive measurements to detect hypotension (invasive mean Arterial Pressure &lt;65 mmHg, systolic Arterial Pressure &lt;90 mmHg), hypertension (invasive mean Arterial Pressure &gt;100 mmHg, systolic Arterial Pressure &gt;140 mmHg), and a significant therapy-induced change in invasive mean Arterial Pressure (&gt;10%) was determined through area under the receiver operating characteristic curve (AUCROC) analysis.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Intensive Care Unit</condition>
    <condition>Arterial Catheter</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patients of a surgical intensive care unit having an arterial catheter</intervention_name>
      <description>Patients of a surgical intensive care unit having an arterial catheter undergoing noninvasive measurements of AP in the two studied positions (semi-recumbent or horizontal).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients of a surgical intensive care unit having an arterial catheter.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria :&#xD;
  &#xD;
            -  Patients having a catheter in the radial artery.&#xD;
  &#xD;
            -  and with stable AP over a 5-min period (no change in invasive mean AP &gt;10% and no&#xD;
               change in vasoactive drugs)&#xD;
  &#xD;
          Exclusion Criteria :&#xD;
  &#xD;
            -  Cardiac arrhythmia.&#xD;
  &#xD;
            -  Dysfunction of the arterial catheter and/or waveform suggesting an over- or an&#xD;
               under-damping.&#xD;
  &#xD;
            -  Arm circumference &gt; 42 cm (measured at mid-arm).&#xD;
  &#xD;
            -  Contraindication to AP measurement at the arm (fracture, wound, amputated limb, limb&#xD;
               ischemia, infection, phlebitis, history of lymph node dissection, venous access used&#xD;
               on this limb and contraindicating inflation, other).&#xD;
  &#xD;
            -  Contraindication to the horizontal supine position or to the semi-recumbent position,&#xD;
               even transiently.&#xD;
  &#xD;
            -  Patient's health condition requiring urgent care that is incompatible with the study&#xD;
               protocol.&#xD;
  &#xD;
            -  Asymmetry of mean AP between the two upper arms (&gt; 5 mmHg) or inability to assess it.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Age &lt;18 years old.&#xD;
  &#xD;
            -  Adult known to be under guardianship or curatorship before inclusion.&#xD;
  &#xD;
            -  Absence of coverage by the French national health insurance (Sécurité sociale).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Nantes University Hospital</name>
        <address>
          <city>Nantes</city>
          <state>Loire-Atlantique</state>
          <zip>44093</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Karim LAKHAL, PH</last_name>
        <phone>33 2 53 48 27 85</phone>
        <email>karim.lakhal@chu-nantes.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ankle</keyword>
    <keyword>Calf</keyword>
    <keyword>Blood pressure determination</keyword>
    <keyword>Catheterization, Peripheral / methods</keyword>
    <keyword>Cuff</keyword>
    <keyword>Oscillometry</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032169
  org study id: RC23_0233
  nct id: NCT06032169
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The upper arm is sometimes inaccessible for arterial pressure (AP) measurement. Placing the
        automatic cuff at the ankle is a common alternative. However, whether AP measurement at the
        ankle is reliable is uncertain. Furthermore, it is unknown whether it is necessary to place
        the patient in a horizontal position to improve the reliability of the measurement, or if
        leaving the patient in default position (often semi-recumbent) is acceptable. The aim of this
        study is to answer these questions. Additionally, investigators will evaluate whether a
        smartphone application that allows for the simple measurement of AP (by gently placing a
        finger on the camera lens) is a valuable alternative to upper arm measurements.
  A question that arises relatively frequently is "when the upper arm is inaccessible, where
        should the investigators place the automatic cuff to measure AP?". Indeed, surgical
        intervention involving the upper limb, a wound, a fracture, or vascular access (temporary
        catheter or arteriovenous fistula) often makes the arm unsuitable for monitoring AP with an
        automatic cuff. The arterial catheter is not devoid of risks (including the loss of precious
        time for its insertion) and is rarely an appropriate alternative, at least in the first
        instance. Thus, the inaccessibility of the upper arm legitimates the frequent placement of
        the automatic cuff at the ankle. However, the automatic cuff has only been validated for
        placement at the upper arm, not at the ankle. Surprisingly, the reliability of ankle AP
        measurements obtained by this positioning of the cuff at the ankle has been little studied:
        only two studies, using arterial catheter as the reference method, are available, one of
        which was in the specific population of patients with obesity. These studies reported that
        the measurement error at the ankle was excessive, but confirmation is necessary.
  
        Patients, especially in acute care settings, are rarely in a strictly horizontal supine
        position. For various reasons, the critically ill patient is rather in a semi-recumbent
        position, meaning that the angle between the trunk and the horizontal axis is between 30 and
        60°. Thus, the cuff placed at the ankle is no longer at the level of the heart and more
        precisely of the phlebostatic axis. This could modify the hydrostatic pressure and lead to
        overestimation of AP compared to a measurement of AP at heart level (on the arm or
        invasively, for example). Indeed, the impact on AP measurement of the height of the upper arm
        relative to the heart has already been demonstrated: the vertical displacement of the upper
        arm changes the measured AP value. Does the angle of elevation of the trunk significantly
        modify the AP measured at the ankle? If so, and since the measurement at the ankle in the
        horizontal supine position (0°) tends to underestimate AP, do the different sources of
        measurement error "cancel out" in the semi-recumbent position? In what position of the trunk
        is it preferable to measure AP at the ankle? The answers to these questions are uncertain.
        Indeed, the only study that investigators are aware of (a pilot study) and that specifically
        addressed this issue did not provide clear answers. This is important since AP is a crucial
        parameter of monitoring and therefore of therapeutic decision-making. It is remarkable that
        in acute care settings, little to no attention is paid to trunk elevation when measuring BP
        at the ankle, and of course, there is no automation of patient positioning (e.g., in a
        horizontal position) prior to each automatic measurement at the ankle.
  
        Therefore, it appears important to evaluate the accuracy and precision of non-invasive ankle
        measurements of AP and the impact of patient position on it. This will be the main objective
        of the study. If these ankle measurements prove to be neither accurate nor precise, having an
        alternative would be desirable. It is noteworthy that when the arm is inaccessible, the
        finger often is. AP measurement at the finger is now possible with a simple smartphone. This
        finger measurement requires calibration with one or two automatic cuff measurements, which
        should be possible in most cases (the arm is frequently inaccessible for prolonged AP
        monitoring, but still allows for one or two isolated measurements). So, which is the better
        alternative site for AP measurement, the finger or ankle? AP measurement using a smartphone
        has never been evaluated from this perspective. This will be a secondary objective of the
        study.
  observational model: Case-Control
  time perspective: Prospective
  measure: To evaluate whether the non-invasive measurement error of ankle mean Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal).
  time frame: 15 minutes
  description: The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.
  The reference AP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one.
  measure: To evaluate whether the non-invasive measurement error of ankle systolic and diastolic Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal).
  time frame: 15 minutes
  description: The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.
  measure: To evaluate whether the non-invasive measurement error of mean, systolic and diastolic Arterial Pressure at the upper arm is acceptable in either patient position (semi-recumbent or horizontal).
  time frame: 15 minutes
  description: The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.
  measure: To evaluate whether the non-invasive measurement error of mean, systolic and diastolic Arterial Pressure with a smartphone is acceptable.
  time frame: 15 minutes
  description: The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.
  measure: To evaluate the risk associated with measurement errors of systolic and mean Arterial Pressure with each technique at each position.
  time frame: 15 minutes
  description: Via a dedicated error grid, the risk associated with measurement errors was classified into one of the 5 risk levels ranging from "no risk" to "dangerous risk". Distribution across the different risk levels was compared by Fisher exact tests.
  measure: To evaluate the ability of noninvasive measurements to detect hypo-/hypertension.
  time frame: 15 minutes
  description: The ability of averaged noninvasive measurements to detect hypotension (invasive mean Arterial Pressure <65 mmHg, systolic Arterial Pressure <90 mmHg), hypertension (invasive mean Arterial Pressure >100 mmHg, systolic Arterial Pressure >140 mmHg), and a significant therapy-induced change in invasive mean Arterial Pressure (>10%) was determined through area under the receiver operating characteristic curve (AUCROC) analysis.
  intervention type: Other
  intervention name: Patients of a surgical intensive care unit having an arterial catheter
  description: Patients of a surgical intensive care unit having an arterial catheter undergoing noninvasive measurements of AP in the two studied positions (semi-recumbent or horizontal).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  sharing ipd: Undecided