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TEE Image Quality Improvement With Our Devised Probe Cover

NCT ID: NCT03812185

Last Updated: 2023-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Image Quality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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TEE image before and after 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.

Group Type OTHER

Suctioning orogastric tube which is attached to TEE probe cover

Intervention Type DEVICE

Suctioning orogastric tube which is atttached to TEE probe cover.

Interventions

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Suctioning orogastric tube which is attached to TEE probe cover

Suctioning orogastric tube which is atttached to TEE probe cover.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Hospital

OTHER

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Yoshihisa Morita

Principal INvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HFHS

Detroit, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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11958

Identifier Type: -

Identifier Source: org_study_id