Back to resultsThe Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
Primary Purpose
Critically Ill
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transesophageal echocardiography
Sponsored by
About this trial
This is an interventional screening trial for Critically Ill focused on measuring transesophageal echocardiography, intensive care unit
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- There is a tee test taboo and clinicians evaluate the risk over benefit
- Did not sign an informed consent form
Sites / Locations
- Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical SciencesRecruiting
- Xiangya Hospital Central South University
- The People's Hospital of Guangxi Zhuang Autonomous Region
- The First Hospital of China Medical University
- Zhongnan Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TEE group
TTE group
Arm Description
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,
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,
Outcomes
Primary Outcome Measures
Conclusion of the adoption
Researcher C conducted a questionnaire survey on attending physician to evaluate the effect
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03811730
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kang Yan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
transesophageal echocardiography, intensive care unit
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEE group
Arm Type
Experimental
Arm Description
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,
Arm Title
TTE group
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Diagnostic Test
Intervention Name(s)
Transesophageal echocardiography
Other Intervention Name(s)
Transthoracic echocardiography
Intervention Description
Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results
Primary Outcome Measure Information:
Title
Conclusion of the adoption
Description
Researcher C conducted a questionnaire survey on attending physician to evaluate the effect
Time Frame
48 hours after completion of the examination
Secondary Outcome Measure Information:
Title
adverse events
Description
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
Time Frame
completion of the examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
There is a tee test taboo and clinicians evaluate the risk over benefit
Did not sign an informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Li, PhD
Phone
(+86)13438168612
Email
526563716@qq.com
Facility Information:
Facility Name
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Zhao
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenghuan Hu, PhD
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liwen Lv
Facility Name
The First Hospital of China Medical University
City
Shengyang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohan Yin
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhan Cai, PhD
12. IPD Sharing Statement
Learn more about this trial
The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
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