The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU

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 .

Study Overview

• Status: Recruiting
• Conditions: Critically Ill
• Intervention / Treatment: Diagnostic test: Transesophageal echocardiography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Li, PhD; Phone Number: (+86)13438168612; Email: 526563716@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
    • Contact: Hua Zhao
  • Changsha, China
    • Not yet recruiting
    • Xiangya Hospital Central South University
    • Contact: Chenghuan Hu, PhD
  • Nanning, China
    • Not yet recruiting
    • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Contact: Liwen Lv
  • Shengyang, China
    • Not yet recruiting
    • The First Hospital of China Medical University
    • Contact: Xiaohan Yin
  • Wuhan, China
    • Not yet recruiting
    • Zhongnan Hospital of Wuhan University
    • Contact: Shuhan Cai, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEE group; Eligible patients would be conducted TEE examination by researcher A,The examination results are judged by A and provided to the physician of this patient,	Diagnostic test: Transesophageal echocardiography; Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results; Other Names: Transthoracic echocardiography
Active Comparator: TTE group; Eligible patients would be conducted TTE examination by researcher B,The examination results are judged by B and provided to the physician of this patient,	Diagnostic test: Transesophageal echocardiography; Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results; Other Names: Transthoracic echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conclusion of the adoption	Researcher C conducted a questionnaire survey on attending physician to evaluate the effect	48 hours after completion of the examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Adverse events associated with the examination，eg.1.Anesthetic allergy;2.Nausea, vomiting, choking cough or aspiration;3.Laryngeal edema and even asphyxiation;4.Severe arrhythmia;5.Esophageal perforation, bleeding, or local hematoma;6.Other accidental deaths, such as acute myocardial infarction, shock, haemorrhage and possibly even death;7.Other unpredictable contingencies or complications	completion of the examination

Collaborators and Investigators

• Sponsor: Kang Yan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: intensive care unit; transesophageal echocardiography
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: TEE

Drug and device information, study documents

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