The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU

NCT ID: NCT03811730

Last Updated: 2021-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Critically Ill

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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,

Group Type EXPERIMENTAL

Transesophageal echocardiography

Intervention Type DIAGNOSTIC_TEST

Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results

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,

Group Type ACTIVE_COMPARATOR

Transesophageal echocardiography

Intervention Type DIAGNOSTIC_TEST

Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results

Interventions

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Transesophageal echocardiography

Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Transthoracic echocardiography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kang Yan

OTHER

Sponsor Role lead

Responsible Party

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Kang Yan

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Xiangya Hospital Central South University

Changsha, , China

Site Status NOT_YET_RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, , China

Site Status NOT_YET_RECRUITING

The First Hospital of China Medical University

Shengyang, , China

Site Status NOT_YET_RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Yi Li, PhD

Role: CONTACT

(+86)13438168612

Facility Contacts

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Hua Zhao

Role: primary

Chenghuan Hu, PhD

Role: primary

Liwen Lv

Role: primary

Xiaohan Yin

Role: primary

Shuhan Cai, PhD

Role: primary

Other Identifiers

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TEE

Identifier Type: -

Identifier Source: org_study_id

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