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临床试验/NCT03812185
NCT03812185已完成不适用

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

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Cardiac procedures and liver transplants which had intraoperative TEE -

排除标准

  • general contraindication with TEE, apparent complications which are related to TEE.

结局指标

主要结局

Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning

时间窗: 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.

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)

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoshihisa Morita

Principal INvestigator

Henry Ford Health System

研究点 (2)

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