Clinical trial NCT03812185: TEE Image Quality Improvement With Our Devised Probe Cover
Official title: TEE Image Quality Improvement With Our Devised Transesophageal Echocardiography Probe Cover and Its Effect on Surgical Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Image Quality
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Henry Ford Hospital
First posted: 2019-01-23
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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

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.

Eligibility criteria: Inclusion Criteria: Cardiac procedures and liver transplants which had intraoperative TEE -

Exclusion Criteria: general contraindication with TEE, apparent complications which are related to TEE.

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Primary outcomes:
measure: Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning
timeFrame: TEE image sets were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images.
Secondary outcomes:
measure: Reproducibility of the LV FAC (Inter-observer)
timeFrame: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).
measure: Reproducibility of the LV FAC (Intra-observer)
timeFrame: 6-8 months after initial images obtained during surgery.
measure: Reproducibility of the RV FAC (Inter-observer)
timeFrame: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).
measure: Reproducibility of the RV FAC (Intra-observer)
timeFrame: 6-8 months after initial images obtained during surgery.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: HFHS
state: Michigan
Study officials:
References: