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临床试验/NCT03811730
NCT03811730Unknown不适用

The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU

Kang Yan5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
5
主要终点
Conclusion of the adoption

研究概览

简要总结

Transesophageal ultrasound offers imaging through the esophagus on the surface of the heart, with good image quality and unique advantages. However, no studies to date have examined its effect in critically ill patients in China.Therefore, the investigators aimed to compare the efficacy and safety of TEE with TTE. the investigators will conducte a Multi-center, prospective observational control study enrolling critically ill adult patients in several ICU in China .

详细描述

Patients in ICU were assessed for the need for TEE by trained researcher. Eligible patients would be conducted tee examination by researcher A, TTE by the researcher B ,at the same time, researcher C records the basic condition and clinical data of patientsand carried out micro-enlargement test.The examination results are judged by A and B respectively and provided to the physician of this patient, and A return visit to the physician wold be conducted by researcher D to evaluate the acceptance of TTE and TEE results and judge the clinical effects. The primary outcome is the clinical effects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The quality of Transthoracic echocardiography is poor ( >3 sections cannot be obtained or the inner membrane is not clear)
  • The diagnosis of the etiology by Transthoracic ultrasonography is still unclear
  • The results of Transthoracic ultrasonography are inconsistent with clinical judgment or cannot explain the existing signs.
  • No obvious improvement or even aggravation after thoracic examination and corresponding treatment
  • Special conditions or clinical scenarios
  • Other clinicians think a TEE check is required.

排除标准

  • There is a tee test taboo and clinicians evaluate the risk over benefit
  • Did not sign an informed consent form

结局指标

主要结局

Conclusion of the adoption

时间窗: 48 hours after completion of the examination

Researcher C conducted a questionnaire survey on attending physician to evaluate the effect

次要结局

  • adverse events(completion of the examination)

研究者

发起方
Kang Yan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kang Yan

Director

West China Hospital

研究点 (5)

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