TEE Image Quality Improvement With Our Devised Probe Cover

TEE Image Quality Improvement With Our Devised Transesophageal Echocardiography Probe Cover and Its Effect on Surgical Decision Making

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

Study Overview

• Status: Completed
• Conditions: Image Quality
• Intervention / Treatment: Device: Suctioning orogastric tube which is attached to TEE probe cover

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • HFHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Suctioning orogastric tube which is attached to TEE probe cover; Suctioning orogastric tube which is atttached to TEE probe cover.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning	Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the LV FAC (Inter-observer)	The reproducibility of the LV FAC was assessed, assuming that better image quality would yield better LV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. These image sets are combined and assessment was done for each group (i.e. before and after suctioning)	Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).
Reproducibility of the LV FAC (Intra-observer)	Investigator C analyzed all image sets again in 6-8 months to determine if there was intra-observer variability with the initial assessment of image quality. All investigators were blinded to which images were obtained before or after suctioning.	6-8 months after initial images obtained during surgery.
Reproducibility of the RV FAC (Inter-observer)	The reproducibility of the RV FAC was assessed, assuming that better image quality would yield better RV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc.	Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).
Reproducibility of the RV FAC (Intra-observer)	Investigator C analyzed all image sets again in 6-8 months to determine if there was intra-observer variability with the initial assessment of image quality. All investigators were blinded to which images were obtained before or after suctioning.	6-8 months after initial images obtained during surgery.

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 11958

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes