Critically IllNCT03811730
The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
A study testing Transesophageal echocardiography in people with Critically Ill, run by Kang Yan at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Transesophageal echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 1 Mar 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There is a tee test taboo and clinicians evaluate the risk over benefit
- Did not sign an informed consent form
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing
Hua Zhao
- Not yet recruiting
Xiangya Hospital Central South University
Changsha
Chenghuan Hu, PhD
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
Liwen Lv
- Not yet recruiting
The First Hospital of China Medical University
Shengyang
Xiaohan Yin
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Shuhan Cai, PhD
About this study
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 .
Read the 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.
- Conditions
- Critically Ill
- Being tested
- Transesophageal echocardiography
- Keywords
- transesophageal echocardiography, intensive care unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiographyDiagnostic test
Also called Transthoracic echocardiography
Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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, Receives: Diagnostic Test: Transesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conclusion of the adoption
Researcher C conducted a questionnaire survey on attending physician to evaluate the effect
Measured: 48 hours after completion of the examination
Secondary outcomes (1)
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
Measured: completion of the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Mar 2019
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kang Yan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811730
- Sponsor's protocol ID
- TEE
- Status last verified
- Jul 2021
- First submitted
- 10 Jan 2019
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU
- ClinicalTrials.gov ID
- NCT03811730
- Acronym / sponsor ID
- TEE
- Conditions
- Critically Ill
- Keywords
- transesophageal echocardiography, intensive care unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kang YanUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEE group | Experimental | Diagnostic Test: Transesophageal echocardiographyEligible patients would be conducted TEE examination by researcher A,The examination results are judged by A and provided to the physician of this patient, |
| TTE group | Active comparator | Diagnostic Test: Transesophageal echocardiographyEligible patients would be conducted TTE examination by researcher B,The examination results are judged by B and provided to the physician of this patient, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- There is a tee test taboo and clinicians evaluate the risk over benefit
- Did not sign an informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiographyAlso: Transthoracic echocardiographyEligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results | Diagnostic test | TEE group, TTE group |
Primary outcome
Conclusion of the adoption
Time frame: 48 hours after completion of the examination
Researcher C conducted a questionnaire survey on attending physician to evaluate the effect
1 secondary outcome
adverse events
Time frame: completion of the examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transesophageal echocardiography in people with Critically Ill, run by Kang Yan at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Li, PhD ((+86)13438168612, 526563716@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conclusion of the adoption (time frame: 48 hours after completion of the examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.