TEE Image Quality Improvement With Our Devised Probe Cover

Image Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812185
• Other study ID #: 11958
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Image Quality

Intervention

Device:
• Suctioning orogastric tube which is attached to TEE probe cover
Suctioning orogastric tube which is atttached to TEE probe cover.

Locations

Country	Name	City	State
United States	HFHS	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Henry Ford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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.
Secondary	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).
Secondary	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.