Clinical trial NCT03811730: The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
Official title: The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill
Keywords: transesophageal echocardiography
intensive care unit
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Conclusion of the adoption
timeFrame: 48 hours after completion of the examination
Secondary outcomes:
measure: adverse events
timeFrame: completion of the examination
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Shengyang
country: China
facility: The First Hospital of China Medical University
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
Study officials:
References: