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TEE Image Quality Improvement With Our Devised Probe Cover

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ClinicalTrials.gov Identifier: NCT03812185
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Henry Ford Hospital
Information provided by (Responsible Party):
Yoshihisa Morita, Henry Ford Health System

Brief Summary:
With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making.

Condition or disease Intervention/treatment Phase
Image Quality Device: Suctioning orogastric tube which is attached to TEE probe cover Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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
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
Primary Purpose: Diagnostic
Official Title: TEE Image Quality Improvement With Our Devised Transesophageal Echocardiography Probe Cover and Its Effect on Surgical Decision Making
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
No Intervention: TEE image before suctioning orogastric tube
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.
Experimental: TEE image after suctioning orogastric tube
This Arm is TEE image AFTER suctioning
Device: Suctioning orogastric tube which is attached to TEE probe cover
Suctioning orogastric tube which is atttached to TEE probe cover.




Primary Outcome Measures :
  1. Image quality assessment before/after suctioning [ Time Frame: INtraoperative (10 minutes estimated for suctioning and acquiring necessary images) ]
    Image quality assessment by Likert scale before/after suctioning, appropriate measuring using images stored before/after suctioning



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: OLT which had intraoperative TEE -

Exclusion Criteria: general contraindication with TEE, Inability to obtain image to measure HVF using TEE

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812185


Locations
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United States, Michigan
HFHS Recruiting
Detroit, Michigan, United States, 48202
Contact: Kelly Jones    313-874-4420    kjones1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Henry Ford Hospital

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Responsible Party: Yoshihisa Morita, Principal INvestigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03812185     History of Changes
Other Study ID Numbers: 11958
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No