<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/NCT04440904</url>
  </required_header>
  <id_info>
    <org_study_id>2019-333</org_study_id>
    <nct_id>NCT04440904</nct_id>
  </id_info>
  <brief_title>Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography</brief_title>
  <official_title>Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography：A Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Aortic balloon occlusion can be used by emergency physicians to rescue patients with massive&#xD;
      bleeding.The purpose of this study is to study the anatomical characteristics of aortic&#xD;
      balloon occlusion based on aortic CT angiography, so as to provide evidence for improving the&#xD;
      success rate of aortic balloon occlusion guided by body surface markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
&#xD;
      This study is a retrospective descriptive study. The study will be conducted by Radiology&#xD;
      Department, Second Affiliated Hospital, Zhejiang University.&#xD;
&#xD;
      Selection of patients:&#xD;
&#xD;
      The investigators included 57 patients who underwent enhanced contrast full-length aortic CTA&#xD;
      scanning in the Radiology Department of Grade 3A General Hospital affiliated to a university&#xD;
      from April to December 2019. Data of all participants following no apparent vascular&#xD;
      tortuosity in CT diagnosis aged 18-70 years with contrast-enhanced computed tomography (CT)&#xD;
      images of chest, abdomen, and pelvis from April to December in 2019 were analyzed.&#xD;
      Participants whose images accompanied by vascular malformation, poor contrast enhancement,&#xD;
      and history of aortic surgery were precluded.&#xD;
&#xD;
      Method General data of patients were collected through the hospital's electronic medical&#xD;
      record system, including age, sex, height, weight, average body mass index ((Body Mass&#xD;
      Index,BMI), history of surgery, etc.&#xD;
&#xD;
      The CTA examination of the participants' full aorta was performed with a 128-slice&#xD;
      dual-energy CT scanner (Siemens, Germany), and the images were saved in the database. After&#xD;
      screening the suitable participants, the images were transmitted to the CT workstation (Syngo&#xD;
      VB10B Image processing system, Siemens, Germany). Multiplanar reconstruction, curvature plane&#xD;
      reconstruction, and volume rendering were used for three-dimensional reconstruction. The&#xD;
      diameters and lengths of blood vessels and the distances on the body surface were measured.&#xD;
      The diameters of blood vessels included the diameter of the aorta at the edge of left&#xD;
      subclavian artery, celiac trunk, lowest renal artery, and aortic bifurcation. The&#xD;
      intravascular length included the lengths of zone I, zone II, zone III and the descending&#xD;
      aorta. The length from the bilateral femoral artery puncture site to the midpoint of zone I&#xD;
      and III, left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation,&#xD;
      and the distances on the body surface included the distance from the bilateral femoral artery&#xD;
      puncture site to the suprasternal notch, xiphoid process and umbilicus.&#xD;
&#xD;
      The results were described as mean ±standard deviation. SPSS20.0 software (IBM, USA) was used&#xD;
      for analysis. Paired sample t-test was used to compare the differences between the left and&#xD;
      right sides of the data. The difference was statistically significant when the P value was&#xD;
      less than 0.05.&#xD;
&#xD;
      Data Management and Confidentiality Data Management: Using paper version for data management&#xD;
      and storage. The person responsible for collecting paper version will input data in Excel&#xD;
      database, summary paper and electronic versions for further statistical analysis and&#xD;
      preservation.&#xD;
&#xD;
      Security measures: All records related to the identity of participants are to be confidential&#xD;
      and not open to the public outside the scope of relevant laws or regulations.&#xD;
&#xD;
      Informed consent: This study is a retrospective study. Retrospective measurement of&#xD;
      participants' previous aortic CTA imaging data does not infringe upon the interests of&#xD;
      participants, so informed consent can be exempted.&#xD;
&#xD;
      Possible risks of participating in this study: disclosure of personal information.&#xD;
&#xD;
      Precautions against possible risks:&#xD;
&#xD;
        1. All the experimental data of the paper version and the electronic version shall be kept&#xD;
           by the person in charge of the test data.&#xD;
&#xD;
        2. Close the measurement software in time after the end of the study, and confirm that the&#xD;
           personal information has been cleared.&#xD;
&#xD;
      Intervention measures for possible risks:&#xD;
&#xD;
      If there is a disclosure of personal information, it is necessary to record the research&#xD;
      report form and inform the person in charge of the research to intervene in time, and notify&#xD;
      the Ethics Committee immediately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The length from the bilateral femoral artery puncture site to the left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation</measure>
    <time_frame>within 24 hours</time_frame>
    <description>The lengths of the blood vessels were measured along the centerline of the blood vessels by multiplanar reconstruction and curvature plane reconstruction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The distances on the body surface from the bilateral femoral artery puncture site to the suprasternal notch, xiphoid process and umbilicus</measure>
    <time_frame>within 24 hours</time_frame>
    <description>The distances between the body surface mark were measured by using volume-rendering reconstruction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the length of zone I</measure>
    <time_frame>within 24 hours</time_frame>
    <description>defined as the distance from the left subclavian artery to the celiac trunk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the length of zone II</measure>
    <time_frame>within 24 hours</time_frame>
    <description>defined as the distance from the celiac trunk to the lowest renal artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the length of zone III</measure>
    <time_frame>within 24 hours</time_frame>
    <description>defined as the distance from the lowest renal artery to the aortic bifurcation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>CT Angiography</condition>
  <condition>Marker; Structural</condition>
  <arm_group>
    <arm_group_label>Characteristic of aortic length and body surface mark</arm_group_label>
    <description>The diameters and lengths of blood vessels and the distances on the body surface were measured by three-dimensional reconstruction using related Software on CT Workstation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT workstation (Syngo Via VB10B, Siemens, Germany)</intervention_name>
    <description>Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction to measure the diameters and lengths of blood vessels and the distances on the body surface</description>
    <arm_group_label>Characteristic of aortic length and body surface mark</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We conduct an observational retrospective study.The patients underwent aortic CT&#xD;
        angiography examination in the radiology department of the hospital from April to December&#xD;
        in 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complete full-length CTA scan of aorta&#xD;
&#xD;
          -  Aged 18-70 years old&#xD;
&#xD;
          -  No obvious tortuosity diagnosed by CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aortic dissection&#xD;
&#xD;
          -  Aortic aneurysm&#xD;
&#xD;
          -  Severe aortic malformation&#xD;
&#xD;
          -  Severe aortic plaque&#xD;
&#xD;
          -  History of aortic operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Second Affiliated Hospital, Zhejiang University School of Medicine &amp; Institute of Emergency Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>White JM, Cannon JW, Stannard A, Markov NP, Spencer JR, Rasmussen TE. Endovascular balloon occlusion of the aorta is superior to resuscitative thoracotomy with aortic clamping in a porcine model of hemorrhagic shock. Surgery. 2011 Sep;150(3):400-9. doi: 10.1016/j.surg.2011.06.010.</citation>
    <PMID>21878225</PMID>
  </reference>
  <reference>
    <citation>Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.</citation>
    <PMID>22182896</PMID>
  </reference>
  <reference>
    <citation>Linnebur M, Inaba K, Haltmeier T, Rasmussen TE, Smith J, Mendelsberg R, Grabo D, Demetriades D. Emergent non-image-guided resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter placement: A cadaver-based study. J Trauma Acute Care Surg. 2016 Sep;81(3):453-7. doi: 10.1097/TA.0000000000001106.</citation>
    <PMID>27192466</PMID>
  </reference>
  <reference>
    <citation>Okada Y, Narumiya H, Ishi W, Iiduka R. Anatomical landmarks for safely implementing resuscitative balloon occlusion of the aorta (REBOA) in zone 1 without fluoroscopy. Scand J Trauma Resusc Emerg Med. 2017 Jul 3;25(1):63. doi: 10.1186/s13049-017-0411-z.</citation>
    <PMID>28673353</PMID>
  </reference>
  <reference>
    <citation>Eliason JL, Derstine BA, Horbal SR, Wang NC, Holcombe SA, Chiu CH, Ross BE, Bromwell B, Morrison J, Wang SC. Computed tomography correlation of skeletal landmarks and vascular anatomy in civilian adult trauma patients: Implications for resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S138-S145. doi: 10.1097/TA.0000000000002247.</citation>
    <PMID>31246918</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CT angiography</keyword>
  <keyword>Aorta</keyword>
  <keyword>Anatomy</keyword>
  <keyword>Aortic balloon occlusion</keyword>
  <keyword>Body surface markers</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04440904
org study id: 2019-333
nct id: NCT04440904
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aortic balloon occlusion can be used by emergency physicians to rescue patients with massive
      bleeding.The purpose of this study is to study the anatomical characteristics of aortic
      balloon occlusion based on aortic CT angiography, so as to provide evidence for improving the
      success rate of aortic balloon occlusion guided by body surface markers.
Study Design:

      This study is a retrospective descriptive study. The study will be conducted by Radiology
      Department, Second Affiliated Hospital, Zhejiang University.

      Selection of patients:

      The investigators included 57 patients who underwent enhanced contrast full-length aortic CTA
      scanning in the Radiology Department of Grade 3A General Hospital affiliated to a university
      from April to December 2019. Data of all participants following no apparent vascular
      tortuosity in CT diagnosis aged 18-70 years with contrast-enhanced computed tomography (CT)
      images of chest, abdomen, and pelvis from April to December in 2019 were analyzed.
      Participants whose images accompanied by vascular malformation, poor contrast enhancement,
      and history of aortic surgery were precluded.

      Method General data of patients were collected through the hospital's electronic medical
      record system, including age, sex, height, weight, average body mass index ((Body Mass
      Index,BMI), history of surgery, etc.

      The CTA examination of the participants' full aorta was performed with a 128-slice
      dual-energy CT scanner (Siemens, Germany), and the images were saved in the database. After
      screening the suitable participants, the images were transmitted to the CT workstation (Syngo
      VB10B Image processing system, Siemens, Germany). Multiplanar reconstruction, curvature plane
      reconstruction, and volume rendering were used for three-dimensional reconstruction. The
      diameters and lengths of blood vessels and the distances on the body surface were measured.
      The diameters of blood vessels included the diameter of the aorta at the edge of left
      subclavian artery, celiac trunk, lowest renal artery, and aortic bifurcation. The
      intravascular length included the lengths of zone I, zone II, zone III and the descending
      aorta. The length from the bilateral femoral artery puncture site to the midpoint of zone I
      and III, left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation,
      and the distances on the body surface included the distance from the bilateral femoral artery
      puncture site to the suprasternal notch, xiphoid process and umbilicus.

      The results were described as mean ±standard deviation. SPSS20.0 software (IBM, USA) was used
      for analysis. Paired sample t-test was used to compare the differences between the left and
      right sides of the data. The difference was statistically significant when the P value was
      less than 0.05.

      Data Management and Confidentiality Data Management: Using paper version for data management
      and storage. The person responsible for collecting paper version will input data in Excel
      database, summary paper and electronic versions for further statistical analysis and
      preservation.

      Security measures: All records related to the identity of participants are to be confidential
      and not open to the public outside the scope of relevant laws or regulations.

      Informed consent: This study is a retrospective study. Retrospective measurement of
      participants' previous aortic CTA imaging data does not infringe upon the interests of
      participants, so informed consent can be exempted.

      Possible risks of participating in this study: disclosure of personal information.

      Precautions against possible risks:

        1. All the experimental data of the paper version and the electronic version shall be kept
           by the person in charge of the test data.

        2. Close the measurement software in time after the end of the study, and confirm that the
           personal information has been cleared.

      Intervention measures for possible risks:

      If there is a disclosure of personal information, it is necessary to record the research
      report form and inform the person in charge of the research to intervene in time, and notify
      the Ethics Committee immediately.
observational model: Cohort
time perspective: Retrospective
measure: The length from the bilateral femoral artery puncture site to the left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation
time frame: within 24 hours
description: The lengths of the blood vessels were measured along the centerline of the blood vessels by multiplanar reconstruction and curvature plane reconstruction
measure: The distances on the body surface from the bilateral femoral artery puncture site to the suprasternal notch, xiphoid process and umbilicus
time frame: within 24 hours
description: The distances between the body surface mark were measured by using volume-rendering reconstruction
measure: the length of zone I
time frame: within 24 hours
description: defined as the distance from the left subclavian artery to the celiac trunk
measure: the length of zone II
time frame: within 24 hours
description: defined as the distance from the celiac trunk to the lowest renal artery
measure: the length of zone III
time frame: within 24 hours
description: defined as the distance from the lowest renal artery to the aortic bifurcation
arm group label: Characteristic of aortic length and body surface mark
description: The diameters and lengths of blood vessels and the distances on the body surface were measured by three-dimensional reconstruction using related Software on CT Workstation
intervention type: Device
intervention name: CT workstation (Syngo Via VB10B, Siemens, Germany)
description: Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction to measure the diameters and lengths of blood vessels and the distances on the body surface
arm group label: Characteristic of aortic length and body surface mark
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
citation: White JM, Cannon JW, Stannard A, Markov NP, Spencer JR, Rasmussen TE. Endovascular balloon occlusion of the aorta is superior to resuscitative thoracotomy with aortic clamping in a porcine model of hemorrhagic shock. Surgery. 2011 Sep;150(3):400-9. doi: 10.1016/j.surg.2011.06.010.
PMID: 21878225
citation: Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.
PMID: 22182896
citation: Linnebur M, Inaba K, Haltmeier T, Rasmussen TE, Smith J, Mendelsberg R, Grabo D, Demetriades D. Emergent non-image-guided resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter placement: A cadaver-based study. J Trauma Acute Care Surg. 2016 Sep;81(3):453-7. doi: 10.1097/TA.0000000000001106.
PMID: 27192466
citation: Okada Y, Narumiya H, Ishi W, Iiduka R. Anatomical landmarks for safely implementing resuscitative balloon occlusion of the aorta (REBOA) in zone 1 without fluoroscopy. Scand J Trauma Resusc Emerg Med. 2017 Jul 3;25(1):63. doi: 10.1186/s13049-017-0411-z.
PMID: 28673353
citation: Eliason JL, Derstine BA, Horbal SR, Wang NC, Holcombe SA, Chiu CH, Ross BE, Bromwell B, Morrison J, Wang SC. Computed tomography correlation of skeletal landmarks and vascular anatomy in civilian adult trauma patients: Implications for resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S138-S145. doi: 10.1097/TA.0000000000002247.
PMID: 31246918
responsible party type: Sponsor
sharing ipd: Undecided