<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/NCT03812185</url>
  </required_header>
  <id_info>
    <org_study_id>11958</org_study_id>
    <nct_id>NCT03812185</nct_id>
  </id_info>
  <brief_title>TEE Image Quality Improvement With Our Devised Probe Cover</brief_title>
  <official_title>TEE Image Quality Improvement With Our Devised Transesophageal Echocardiography Probe Cover and Its Effect on Surgical Decision Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Henry Ford Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      With using suction tube attached TEE probe cover, we will assess its pinpoint suction&#xD;
      capacity on image quality and surgical decision making.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Transesophageal echocardiography (TEE) has become a standard intraoperative&#xD;
      diagnosis technique for clinical management of patients during cardiac and non-cardiac&#xD;
      surgery. Accurate intraoperative diagnosis by TEE improves as image quality improves.&#xD;
      Although we recently reported enhanced image quality using a TEE probe with an attached&#xD;
      orogastric tube, its clinical significance is still unknown. Also, we are concerned about&#xD;
      potential clinical complications including damage to the upper gastrointestinal tract due to&#xD;
      its rough surface. Therefore, we devised a new TEE probe cover equipped with a suction&#xD;
      catheter and ultrasound gel containing pad that functions as a cushion for preventing&#xD;
      surrounding tissue trauma. Our long-term goal is to improve TEE image quality, which will&#xD;
      help surgical decision-making with precise assessment. The study population will be elective&#xD;
      cardiac cases and liver transplant cases at Henry Ford Hospital. The objective of this grant&#xD;
      is to assess the image quality change with our newly designed TEE probe, and its clinical&#xD;
      utility on patient care in different types of procedures.&#xD;
&#xD;
      Aim 1. To assess TEE image quality before and after pin-point suctioning with our newly&#xD;
      designed TEE probe. We hypothesize that decreasing stomach air between the TEE probe&#xD;
      transducer and tissue wall by pin-point suction with our newly designed TEE probe will reduce&#xD;
      ultrasound reflection and lead to better image quality.&#xD;
&#xD;
      Aim 2. To evaluate the clinical utility of our newly designed TEE probe cover. We hypothesize&#xD;
      our newly designed TEE probe cover will facilitate decision-making for both anesthesiologists&#xD;
      and surgeons and it will not increase the occurrence of TEE probe related trauma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>For intraoperative TEE used cardiac or transplant cases, investigators will compare TEE image quality before and after suctioning using orogastric tube attached TEE probe cover</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Since this is a single group study, participant, care provider, and investigator will NOT be masked. However, outcome assessor (who assess image quality and perform measurement using stored TEE images) will be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Image quality assessment before/after suctioning</measure>
    <time_frame>INtraoperative (10 minutes estimated for suctioning and acquiring necessary images)</time_frame>
    <description>Image quality assessment by Likert scale before/after suctioning, appropriate measuring using images stored before/after suctioning</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Image Quality</condition>
  <arm_group>
    <arm_group_label>TEE image before suctioning orogastric tube</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TEE image after suctioning orogastric tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This Arm is TEE image AFTER suctioning</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Suctioning orogastric tube which is attached to TEE probe cover</intervention_name>
    <description>Suctioning orogastric tube which is atttached to TEE probe cover.</description>
    <arm_group_label>TEE image after suctioning orogastric tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Cardiac procedures and liver transplants which had intraoperative TEE -&#xD;
&#xD;
        Exclusion Criteria: general contraindication with TEE, apparent complications which are&#xD;
        related to TEE.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HFHS</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>December 27, 2020</last_update_submitted>
  <last_update_submitted_qc>December 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Yoshihisa Morita</investigator_full_name>
    <investigator_title>Principal INvestigator</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>January 26, 2022</submitted>
    <returned>February 17, 2022</returned>
    <submitted>December 10, 2022</submitted>
    <returned>January 4, 2023</returned>
    <submitted>January 22, 2023</submitted>
    <returned>February 16, 2023</returned>
    <submitted>February 23, 2023</submitted>
    <returned>March 22, 2023</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/NCT03812185
org study id: 11958
nct id: NCT03812185
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
With using suction tube attached TEE probe cover, we will assess its pinpoint suction
      capacity on image quality and surgical decision making.
Background: Transesophageal echocardiography (TEE) has become a standard intraoperative
      diagnosis technique for clinical management of patients during cardiac and non-cardiac
      surgery. Accurate intraoperative diagnosis by TEE improves as image quality improves.
      Although we recently reported enhanced image quality using a TEE probe with an attached
      orogastric tube, its clinical significance is still unknown. Also, we are concerned about
      potential clinical complications including damage to the upper gastrointestinal tract due to
      its rough surface. Therefore, we devised a new TEE probe cover equipped with a suction
      catheter and ultrasound gel containing pad that functions as a cushion for preventing
      surrounding tissue trauma. Our long-term goal is to improve TEE image quality, which will
      help surgical decision-making with precise assessment. The study population will be elective
      cardiac cases and liver transplant cases at Henry Ford Hospital. The objective of this grant
      is to assess the image quality change with our newly designed TEE probe, and its clinical
      utility on patient care in different types of procedures.

      Aim 1. To assess TEE image quality before and after pin-point suctioning with our newly
      designed TEE probe. We hypothesize that decreasing stomach air between the TEE probe
      transducer and tissue wall by pin-point suction with our newly designed TEE probe will reduce
      ultrasound reflection and lead to better image quality.

      Aim 2. To evaluate the clinical utility of our newly designed TEE probe cover. We hypothesize
      our newly designed TEE probe cover will facilitate decision-making for both anesthesiologists
      and surgeons and it will not increase the occurrence of TEE probe related trauma.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: For intraoperative TEE used cardiac or transplant cases, investigators will compare TEE image quality before and after suctioning using orogastric tube attached TEE probe cover
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: Since this is a single group study, participant, care provider, and investigator will NOT be masked. However, outcome assessor (who assess image quality and perform measurement using stored TEE images) will be masked
measure: Image quality assessment before/after suctioning
time frame: INtraoperative (10 minutes estimated for suctioning and acquiring necessary images)
description: Image quality assessment by Likert scale before/after suctioning, appropriate measuring using images stored before/after suctioning
arm group label: TEE image before suctioning orogastric tube
arm group type: No Intervention
description: for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.
arm group label: TEE image after suctioning orogastric tube
arm group type: Experimental
description: This Arm is TEE image AFTER suctioning
intervention type: Device
intervention name: Suctioning orogastric tube which is attached to TEE probe cover
description: Suctioning orogastric tube which is atttached to TEE probe cover.
arm group label: TEE image after suctioning orogastric tube
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Yoshihisa Morita
investigator title: Principal INvestigator
submitted: January 26, 2022
returned: February 17, 2022
submitted: December 10, 2022
returned: January 4, 2023
submitted: January 22, 2023
returned: February 16, 2023
submitted: February 23, 2023
returned: March 22, 2023