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/NCT06007209</url>
    </required_header>
    <id_info>
      <org_study_id>2375-2023</org_study_id>
      <nct_id>NCT06007209</nct_id>
    </id_info>
    <brief_title>Blind vs US Guided Manual Pressure Points</brief_title>
    <official_title>Study Protocol: A Randomized Crossover Controlled Human Volunteer Trial Comparing Blind Manual vs. Ultrasound-guided Pressure Point in Combat Medics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tel-Aviv Sourasky Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Israel Defense Forces</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tel-Aviv Sourasky Medical Center</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 goal of this clinical trial is to compare the effectiveness of manual pressure points&#xD;
        (femoral and supra-clavicular) for hemorrhage control by military medics using either the&#xD;
        traditional blind manual technique or an ultrasound guided technique in healthy human&#xD;
        volunteers. The main question to answer is which technique provides better results with&#xD;
        regard to cumulative flow cessation during a 180 seconds attempt.&#xD;
  &#xD;
        Participants will press on each other's supraclavicular and femoral pressure points, twice&#xD;
        each, once with an ultrasound probe and once with their hand, while distal flow is measured&#xD;
        using ultrasound doppler.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Each experimental day will include a maximum of 30 male subjects. Following the signing of an&#xD;
        informed consent form and a questionnaire detailing possible exclusion criteria, subjects'&#xD;
        demographics including age, gender, weight and height will be recorded. Right- or left-hand&#xD;
        dominance, as well as the duration of service and previous training in MPP, will be&#xD;
        determined by questioning and documented. This will be performed in a separate setting,&#xD;
        ensuring subjects' privacy.&#xD;
  &#xD;
        Then, all participants will undergo hands-on training in small groups concerning the pressure&#xD;
        point technique - both blind application and ultrasound-guided application of the technique.&#xD;
        Each participant will have the opportunity to try each technique at least once at each point.&#xD;
  &#xD;
        Following the training session, participants will serve as both providers and models based on&#xD;
        convenience (the order in which they approach the enrollment station), with each provider&#xD;
        ideally becoming the subject for the next provider, although not necessarily. Each subject&#xD;
        (medic) will perform two sets of attempts for pressure points application, on the same side&#xD;
        of the model subject, which will be randomly determined (to avoid a bias created by the&#xD;
        convenience of approach correseponding with providers' hand dominance). Before each set, the&#xD;
        model subject's blood pressure and heart rate will be measured (on the contralateral side to&#xD;
        the pressure application) and recorded. Each set will consist of three 180 seconds long&#xD;
        attempts. Each attempt will be performed at a different point: Supraclavicular and femoral,&#xD;
        with at least 120 seconds break between attempts. One of the sets will be performed using the&#xD;
        blind, manual technique, using the provider's hands, and the other sets will be done using an&#xD;
        ultrasound device guiding the location, direction and amount of pressure and using the probe&#xD;
        itself to exert the pressure. The order in which the sets will be performed will be randomly&#xD;
        determined.&#xD;
  &#xD;
        At any point, any of the subjects can stop and end the attempt due to discomfort or any other&#xD;
        reason. His participation will cease immediately, without the need for an explanation or&#xD;
        taking any steps on his part. In that case, the same attempt (e.g. blind supraclavicular&#xD;
        pressure) will not be repeated. However, this will not preclude the subject from&#xD;
        participating in the following attempts as long as he is willing to.&#xD;
  &#xD;
        At the end of each attempt, both the model and provider will be requested to rate their level&#xD;
        of discomfort between 0 and 10 (NRS - Numerical Rating Score) During each attempt (including&#xD;
        a 10-second baseline recording before each attempt), a sonographer will use a second&#xD;
        ultrasound device to monitor blood flow distal to the pressure point using pulse-wave&#xD;
        doppler. The sonographer will be blinded to the pressure technique used by the participant&#xD;
        using a fabric blind and noise-cancelling headphones. The sonographer will vocally declare&#xD;
        each time occlusion has been achieved or lost. A member of the experiment team will use a&#xD;
        stopwatch to measure the total time of flow within each 180 seconds attempt. In addition,&#xD;
        screen recording of the ultrasound device screen will be performed to allow for retrospective&#xD;
        flow rate analysis using image analysis software. Screen recording of the pressing ultrasound&#xD;
        screen will also be performed for potential retrospective analysis. Following each attempt,&#xD;
        the cross-sectional area and mean flow rate of the artery in the intended pressure location&#xD;
        will be measured by a sonographer to determine baseline flow through the artery, and clips&#xD;
        will be collected to map the anatomy of the area for possible future analysis. This will be&#xD;
        done after the attempt so that no markings will be left to guide the providers in their&#xD;
        attempt.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Sonographer will be masked from the pressure technique used with a fabric blind and noise-cancelling headphones.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>cumulative flow time</measure>
      <time_frame>180 seconds</time_frame>
      <description>The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cumulative flow</measure>
      <time_frame>180 seconds</time_frame>
      <description>A secondary outcome will be the calculated cumulative flow through the compressed point during each attempt</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Junctional Hemorrhage</condition>
    <condition>Extremity Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Ultrasound guided</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using an ultrasound probe visualizing the arteries, the underlying bones and the compression of the arteries.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Blind techniques</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using the medic's hand based on anatomical land marks and palpation of pulse.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Manual Pressure Point</intervention_name>
      <description>Compression of the subclavian artery against the 1st rib and of the common femoral artery against the pelvis.</description>
      <arm_group_label>Blind techniques</arm_group_label>
      <arm_group_label>Ultrasound guided</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years.&#xD;
  &#xD;
            -  Combat pararescue medics who have completed their medics training course.&#xD;
  &#xD;
            -  Informed consent.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Any medical condition that causes or may cause discomfort during the experiment,&#xD;
               including specifically conditions involving the groin, shoulder and neck.&#xD;
  &#xD;
            -  Any known vascular disease, including any known familial hypercoagulability disorder.&#xD;
  &#xD;
            -  Any known peripheral neuropathy.&#xD;
  &#xD;
            -  All of the above will be based on subjects' self-reporting. Subjects will be&#xD;
               encouraged to consult with the unit's physician who will not be part of the study team&#xD;
               but will be briefed about the study protocol.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guy Avital, MD</last_name>
      <role>Study Director</role>
      <affiliation>Israel Defense Forces</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ofer Almog, MD</last_name>
      <role>Study Director</role>
      <affiliation>Israel Defense Forces</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guy Avital, MD</last_name>
      <phone>972-52-8721517</phone>
      <email>guy.avital.md.il@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ofer Almog, MD</last_name>
      <email>ofer18181@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
      <investigator_full_name>Barak Cohen, MD</investigator_full_name>
      <investigator_title>Tel-Aviv Sourasky Medical Center</investigator_title>
    </responsible_party>
    <keyword>Pressure Point, Junctional Hemorrhage</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06007209
  org study id: 2375-2023
  nct id: NCT06007209
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  the goal of this clinical trial is to compare the effectiveness of manual pressure points
        (femoral and supra-clavicular) for hemorrhage control by military medics using either the
        traditional blind manual technique or an ultrasound guided technique in healthy human
        volunteers. The main question to answer is which technique provides better results with
        regard to cumulative flow cessation during a 180 seconds attempt.
  
        Participants will press on each other's supraclavicular and femoral pressure points, twice
        each, once with an ultrasound probe and once with their hand, while distal flow is measured
        using ultrasound doppler.
  Each experimental day will include a maximum of 30 male subjects. Following the signing of an
        informed consent form and a questionnaire detailing possible exclusion criteria, subjects'
        demographics including age, gender, weight and height will be recorded. Right- or left-hand
        dominance, as well as the duration of service and previous training in MPP, will be
        determined by questioning and documented. This will be performed in a separate setting,
        ensuring subjects' privacy.
  
        Then, all participants will undergo hands-on training in small groups concerning the pressure
        point technique - both blind application and ultrasound-guided application of the technique.
        Each participant will have the opportunity to try each technique at least once at each point.
  
        Following the training session, participants will serve as both providers and models based on
        convenience (the order in which they approach the enrollment station), with each provider
        ideally becoming the subject for the next provider, although not necessarily. Each subject
        (medic) will perform two sets of attempts for pressure points application, on the same side
        of the model subject, which will be randomly determined (to avoid a bias created by the
        convenience of approach correseponding with providers' hand dominance). Before each set, the
        model subject's blood pressure and heart rate will be measured (on the contralateral side to
        the pressure application) and recorded. Each set will consist of three 180 seconds long
        attempts. Each attempt will be performed at a different point: Supraclavicular and femoral,
        with at least 120 seconds break between attempts. One of the sets will be performed using the
        blind, manual technique, using the provider's hands, and the other sets will be done using an
        ultrasound device guiding the location, direction and amount of pressure and using the probe
        itself to exert the pressure. The order in which the sets will be performed will be randomly
        determined.
  
        At any point, any of the subjects can stop and end the attempt due to discomfort or any other
        reason. His participation will cease immediately, without the need for an explanation or
        taking any steps on his part. In that case, the same attempt (e.g. blind supraclavicular
        pressure) will not be repeated. However, this will not preclude the subject from
        participating in the following attempts as long as he is willing to.
  
        At the end of each attempt, both the model and provider will be requested to rate their level
        of discomfort between 0 and 10 (NRS - Numerical Rating Score) During each attempt (including
        a 10-second baseline recording before each attempt), a sonographer will use a second
        ultrasound device to monitor blood flow distal to the pressure point using pulse-wave
        doppler. The sonographer will be blinded to the pressure technique used by the participant
        using a fabric blind and noise-cancelling headphones. The sonographer will vocally declare
        each time occlusion has been achieved or lost. A member of the experiment team will use a
        stopwatch to measure the total time of flow within each 180 seconds attempt. In addition,
        screen recording of the ultrasound device screen will be performed to allow for retrospective
        flow rate analysis using image analysis software. Screen recording of the pressing ultrasound
        screen will also be performed for potential retrospective analysis. Following each attempt,
        the cross-sectional area and mean flow rate of the artery in the intended pressure location
        will be measured by a sonographer to determine baseline flow through the artery, and clips
        will be collected to map the anatomy of the area for possible future analysis. This will be
        done after the attempt so that no markings will be left to guide the providers in their
        attempt.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: Sonographer will be masked from the pressure technique used with a fabric blind and noise-cancelling headphones.
  measure: cumulative flow time
  time frame: 180 seconds
  description: The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.
  measure: cumulative flow
  time frame: 180 seconds
  description: A secondary outcome will be the calculated cumulative flow through the compressed point during each attempt
  arm group label: Ultrasound guided
  arm group type: Active Comparator
  description: Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using an ultrasound probe visualizing the arteries, the underlying bones and the compression of the arteries.
  arm group label: Blind techniques
  arm group type: Active Comparator
  description: Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using the medic's hand based on anatomical land marks and palpation of pulse.
  intervention type: Other
  intervention name: Manual Pressure Point
  description: Compression of the subclavian artery against the 1st rib and of the common femoral artery against the pelvis.
  arm group label: Blind techniques
  arm group label: Ultrasound guided
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Guy Avital, MD
  role: Study Director
  affiliation: Israel Defense Forces
  last name: Ofer Almog, MD
  role: Study Director
  affiliation: Israel Defense Forces
  last name: Guy Avital, MD
  phone: 972-52-8721517
  email: guy.avital.md.il@gmail.com
  last name: Ofer Almog, MD
  email: ofer18181@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Tel-Aviv Sourasky Medical Center
  investigator full name: Barak Cohen, MD
  investigator title: Tel-Aviv Sourasky Medical Center
  mesh term: Hemorrhage
  sharing ipd: No