<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/NCT04491331</url>
  </required_header>
  <id_info>
    <org_study_id>UH HradecKralove</org_study_id>
    <nct_id>NCT04491331</nct_id>
  </id_info>
  <brief_title>Hemodynamic Changes Due to Prone Position</brief_title>
  <official_title>Hemodynamic Changes Due to Prone Position in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Hradec Kralove</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Hradec Kralove</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>
      Perioperative prone position may be associated with hemodynamic instability. The causes of&#xD;
      instability have not yet been precisely elucidated. The aim of this study is to demonstrate&#xD;
      physiological changes during prone positioning in healthy volunteers .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prone position could decrease the cardiac index (CI), mainly due to reduction in stroke&#xD;
      volume, with little changes in heart rate. Mean arterial pressure (MAP) could be maintained&#xD;
      by increased systemic vascular resistance (SVR) in the majority of patients.&#xD;
&#xD;
      The aim of this study is to describe hemodynamic changes in two different surgical prone&#xD;
      positions in 10 healthy non-anesthetized volunteers (flat position and using a support system&#xD;
      allowing a free abdomen) by non-invasive measurement of hemodynamics (ClearSight, Edwards)&#xD;
      and indirectly evaluated intra-abdominal pressure using ultrasound. The ClearSight system&#xD;
      provides advanced hemodynamic parameters (cardiac index CI, stroke volume SV, stroke volume&#xD;
      variation SVV, systemic vascular resistance SVR, mean arterial pressure MAP) from a finger&#xD;
      cuff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>Change in Cardiac Index</measure>
    <time_frame>5 minutes</time_frame>
    <description>after changing supine to prone position</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in vena cava diameter</measure>
    <time_frame>5 minutes</time_frame>
    <description>after changing supine to prone position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vena jugularis diameter</measure>
    <time_frame>5 minutes</time_frame>
    <description>after changing supine to prone position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vena saphena diameter</measure>
    <time_frame>5 minutes</time_frame>
    <description>after changing supine to prone position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vena cephalica diameter</measure>
    <time_frame>5 minutes</time_frame>
    <description>after changing supine to prone position</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Hemodynamics Instability</condition>
  <condition>Prone Position</condition>
  <arm_group>
    <arm_group_label>Non-anesthetized volunteers</arm_group_label>
    <description>Hemodynamic parameters will be measured in supine position. Volunteers will be turned into prone position. After a five-minute stabilization phase will be monitored CI, MAP, heart rate (HR), stroke volume variation SVV, systemic vascular resistance index (SVRI) by non-invasive measurements using a ClearSight (Edwards) in two prone positions (lying on support system allowing a free abdomen and then lying flat without any device). Furthermore, the width of the inferior vena cava and vena jugularis interna, vena saphena and vena cephalica will be measured by ultrasound. The measurement will be performed in inspiration and in expiration phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>prone position</intervention_name>
    <description>Unsupported prone position with arms along the body in neutral position will be used first without any supportive device except support of heels with a soft cylindrical device, head will be held in a neutral position using prone head rest. After recording of all measered values, the prone position using the prone position support system will be tested. The support system allows free movement of the lower thorax and abdomenal wall, upper arms are elevated and angled in 90 degrees (in shoulders and elbows). Heels will be positioned at the level of the heart using a supportive cylindrical device. Head will be held in a neutral position using prone head rest.</description>
    <arm_group_label>Non-anesthetized volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        6 male and 6 female healthy, non-anesthetized volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years,&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Physical Status Classification I&#xD;
&#xD;
          -  agreement with study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disagreement with study participation,&#xD;
&#xD;
          -  BMI over 40&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucie Kukralova, MD</last_name>
    <role>Study Director</role>
    <affiliation>UH Hradec Kralove</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Kukrálová L, Dostálová V, Dostál P. Hemodynamic changes in prone position - a non-invasive physiological study. Anest. intenziv. Med.. 2021;32(2):82-86. doi: 10.36290/aim.2021.010.</citation>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>November 25, 2022</last_update_submitted>
  <last_update_submitted_qc>November 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Hradec Kralove</investigator_affiliation>
    <investigator_full_name>Dostalova Vlasta, MD, PhD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>hemodynamics</keyword>
  <keyword>prone position</keyword>
  <keyword>cardiac output</keyword>
  <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/NCT04491331
org study id: UH HradecKralove
nct id: NCT04491331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perioperative prone position may be associated with hemodynamic instability. The causes of
      instability have not yet been precisely elucidated. The aim of this study is to demonstrate
      physiological changes during prone positioning in healthy volunteers .
The prone position could decrease the cardiac index (CI), mainly due to reduction in stroke
      volume, with little changes in heart rate. Mean arterial pressure (MAP) could be maintained
      by increased systemic vascular resistance (SVR) in the majority of patients.

      The aim of this study is to describe hemodynamic changes in two different surgical prone
      positions in 10 healthy non-anesthetized volunteers (flat position and using a support system
      allowing a free abdomen) by non-invasive measurement of hemodynamics (ClearSight, Edwards)
      and indirectly evaluated intra-abdominal pressure using ultrasound. The ClearSight system
      provides advanced hemodynamic parameters (cardiac index CI, stroke volume SV, stroke volume
      variation SVV, systemic vascular resistance SVR, mean arterial pressure MAP) from a finger
      cuff.
observational model: Cohort
time perspective: Prospective
measure: Change in Cardiac Index
time frame: 5 minutes
description: after changing supine to prone position
measure: Changes in vena cava diameter
time frame: 5 minutes
description: after changing supine to prone position
measure: Changes in vena jugularis diameter
time frame: 5 minutes
description: after changing supine to prone position
measure: Changes in vena saphena diameter
time frame: 5 minutes
description: after changing supine to prone position
measure: Changes in vena cephalica diameter
time frame: 5 minutes
description: after changing supine to prone position
arm group label: Non-anesthetized volunteers
description: Hemodynamic parameters will be measured in supine position. Volunteers will be turned into prone position. After a five-minute stabilization phase will be monitored CI, MAP, heart rate (HR), stroke volume variation SVV, systemic vascular resistance index (SVRI) by non-invasive measurements using a ClearSight (Edwards) in two prone positions (lying on support system allowing a free abdomen and then lying flat without any device). Furthermore, the width of the inferior vena cava and vena jugularis interna, vena saphena and vena cephalica will be measured by ultrasound. The measurement will be performed in inspiration and in expiration phase.
intervention type: Procedure
intervention name: prone position
description: Unsupported prone position with arms along the body in neutral position will be used first without any supportive device except support of heels with a soft cylindrical device, head will be held in a neutral position using prone head rest. After recording of all measered values, the prone position using the prone position support system will be tested. The support system allows free movement of the lower thorax and abdomenal wall, upper arms are elevated and angled in 90 degrees (in shoulders and elbows). Heels will be positioned at the level of the heart using a supportive cylindrical device. Head will be held in a neutral position using prone head rest.
arm group label: Non-anesthetized volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lucie Kukralova, MD
role: Study Director
affiliation: UH Hradec Kralove
facility: 
country: Czechia
citation: Kukrálová L, Dostálová V, Dostál P. Hemodynamic changes in prone position - a non-invasive physiological study. Anest. intenziv. Med.. 2021;32(2):82-86. doi: 10.36290/aim.2021.010.
responsible party type: Principal Investigator
investigator affiliation: University Hospital Hradec Kralove
investigator full name: Dostalova Vlasta, MD, PhD
investigator title: Principal investigator
sharing ipd: No