TEE Image Quality Improvement With Our Devised Probe Cover

NCT03812185 | Completed Results FDA Device

• 1 other identifier: 11958
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Image Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reproducibility of the LV FAC (Inter-observer)

  Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).

• Reproducibility of the LV FAC (Intra-observer)

  6-8 months after initial images obtained during surgery.

• Reproducibility of the RV FAC (Inter-observer)

  Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).

• Reproducibility of the RV FAC (Intra-observer)

  6-8 months after initial images obtained during surgery.

Study Arms (1)

TEE image before and after suctioning orogastric tube

OTHER

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

Interventions

Suctioning orogastric tube which is attached to TEE probe cover DEVICE

Suctioning orogastric tube which is atttached to TEE probe cover.

TEE image before and after suctioning orogastric tube

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Henry Ford Health System: lead
• Henry Ford Hospital: collaborator

Study Sites (1)

HFHS

Detroit, Michigan, 48202, United States

Location

Results Point of Contact

• Title: Yoshihisa Morita
• Organization: Henry Ford Health System

moritayoshihisa2016@gmail.com

3059784358

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal INvestigator

Model Details: 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

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: January 1, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 31, 2019
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Locations

US (1)