NCT03811730

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

4.5 years

First QC Date

January 10, 2019

Last Update Submit

July 8, 2021

Conditions

Critically Ill

Keywords

transesophageal echocardiographyintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • adverse events

    completion of the examination

Study Arms (2)

TEE group

EXPERIMENTAL

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

TTE group

ACTIVE COMPARATOR

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

Interventions

Transesophageal echocardiographyDIAGNOSTIC_TEST

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

Also known as: Transthoracic echocardiography
TEE groupTTE group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Beijing, China

RECRUITING

Xiangya Hospital Central South University

Changsha, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shengyang, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Echocardiography, TransesophagealEchocardiography

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Yi Li, PhD

CONTACT

(+86)13438168612526563716@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 22, 2019

Study Start

March 1, 2019

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations

CN(5)