Transesophageal EchocardiographyNCT05960552
Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status
A study testing The PReTEE group and The conventional TEE group in people with Transesophageal Echocardiography, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
We initiate this study to assess the diagnostic efficiency of PReTEE, a simplified TEE scan sequence with a combination of 3 valuable views of ME 4C, ME AV LAX and TG SAX, in identifying cardiac pathologies in the phase of difficult cardiopulmonary bypass separation among patients who will undergo high-risk cardiac… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Transesophageal Echocardiography
- What is being tested?
- The PReTEE group and The conventional TEE group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 yr and greater;
- High-risk cardiac surgery (one of the followings): Baseline left ventricular ejection fraction < 50%, Coronary artery bypass graft combined with valve procedures, Multiple valve procedures (≥ 2), Aortic root or arch involved, Euroscore > 6, Previous cardiovascular surgery
Who cannot join
- Lack of patient consent;
- Esophageal pathology (stricture, tumor, perforation/laceration, ulcer or fistula, diverticulum);
- Hiatus hernia; Perforated viscus;
- Active/recent upper gastrointestinal (GI) bleed;
- Non-elective cardiac procedures;
- Preoperative mechanical cardiac support (ECMO, LVAD or IABP)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Chunrong Wang, MD
About this study
Official title: Establishment and Verification of Clinical Thinking Flowchart of Rescue Transesophageal Echocardiography in the Diagnosis and Treatment of Perioperative Patients in Intensive and Critical Status
We initiate this study to assess the diagnostic efficiency of PReTEE, a simplified TEE scan sequence with a combination of 3 valuable views of ME 4C, ME AV LAX and TG SAX, in identifying cardiac pathologies in the phase of difficult cardiopulmonary bypass separation among patients who will undergo high-risk cardiac surgical procedures.
Read the detailed description
There are 6 TEE operators who will participate in our trial, which is of restriction.
Also, the participants we scheme to include are all junior TEE operators at our institute, who have already skilled at images obtainment and interpretation. Prior to the trial initiation, all these TEE operators will be randomly assigned into either the PReTEE group or the conventional TEE group with a 1:1 ratio (3 per group). Due to another limitation of eligible patients, TEE examinations thereby for patients are not conducted by equal numbers of operators stratified by groups. Furthermore, patients will be examined by 1-4 operators and 1 expert without removing the probe when separated from cardiopulmonary bypass. The ultimate sample size we calculate is 46 TEE examinations.
- Conditions
- Transesophageal Echocardiography
- Being tested
- The PReTEE group, The conventional TEE group
- Keywords
- Transesophageal Echocardiography, Surgery, Rescue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PReTEE groupDiagnostic test
Prior to clinical application of PReTEE, all participants designated must receive professional training. They need to receive lectures focusing on the clinical thinking flowchart of rescue transesophageal echocardiography, in conjuntion with the simulator-based training. The discriminating ability of PReTEE will be further assessed in real clinical scenario, that is, within the specified 120 seconds participants in the PreTEE group need to provide the leading causes with regard to difficult separation from cardiopulmonary bypass in high-risk cardiac surgical procedures. All examinations will be supervised by a TEE expert owning to safety considerations but without help in views acquirement or interpretation. After completion of study assessments, the TEE expert will perform a standard comprehensive TEE, the results of which was reported to the attending cardiac anesthesiologist in charge of the patient and the recorders.
The conventional TEE groupDiagnostic test
Before cardiopulmonary bypass separation, conventional TEE examinations will be performed within the specified 120 seconds. Then, the expert will also perform a standard comprehensive TEE; the leading cause should also be presented to the attending anesthesiologists and recorders.
| Study group | Role | What they receive |
|---|---|---|
| The PReTEE group | Experimental | Prior to clinical application of PReTEE, all participants designated must receive professional training. Within the given 120 seconds participants in the PreTEE group need to provide the leading cause with regard to difficult separation from cardiopulmonary bypass among high-risk cardiac surgical procedures. Receives: Diagnostic Test: The PReTEE group |
| The conventional TEE group | Active comparator | The routine intra-operative TEE examinations are performed within the given 120 seconds before patients are separated from the cardiopulmonary bypass. Receives: Diagnostic Test: The conventional TEE group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken in seconds in seeking out the leading cause of difficult CPB separation.
Time will be recorded in rea-time fashion from the appearance of midesophageal 4 chamber view to the diagnose of leading cause of difficult CPB separation in both the PReTEE group and the conventional group.
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
The rate of successful diagnosis.
Following the completion of TEE assessment by operators in the PreTEE group or in the conventional TEE group, the TEE expert in our center will then perform a standard comprehensive examination. The TEE expert will also be required to provide the leading cause of difficult separation, which then be presented to the attending anesthesiologist and cardiac surgeons as the reference of therapeutic approaches. The successful diagnosis is defined as the agreement of cause between operators in the PreTEE group or in the conventional TEE group and the expert.
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Secondary outcomes (6)
Detection rate of hypovolemia
Reduction in the LV cavity indicates hypovolemia.
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of left ventricular outflow tract obstruction
The occurrence of SAM
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of regional wall motion abnormality
Regional wall motion is commonly classified as 1) normal or hyperkinetic, 2) hypokinetic (reduced thickening), 3) akinetic (absence of thickening), and 4) dyskinetic (systolic thinning or aneurysmal changes
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of left ventricular systolic dysfunction
Left ventricular systolic dysfunction can be assessed as a reduction in systolic function and an increase in diastolic dimension.
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of right ventricular systolic dysfunction
A TEE with a D-shaped LV on trans-gastric short axis view is suggestive of RV volume overload and systolic dysfunction
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of right ventricular outflow tract obstruction
The occurrence of pulmonary embolism, residual thrombus or tumor is seen in the RA/ RV, leftward shift of the interatrial septum or moderate to severe tricuspid regurgitation.
Measured: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Aug 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transesophageal EchocardiographyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960552
- Sponsor's protocol ID
- K3052
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Tian Y, Bai B, He K, Lu H, Yu C, Miao Q. Application of a simplified transesophageal echocardiography examination sequence in high-risk cardiac surgery. Trials. 2024 Aug 13;25(1):535. doi: 10.1186/s13063-024-08338-9.
PubMed 39138581
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Verification of Clinical Thinking Flowchart of Rescue Transesophageal Echocardiography in the Diagnosis and Treatment of Perioperative Patients in Intensive and Critical Status
- ClinicalTrials.gov ID
- NCT05960552
- Acronym / sponsor ID
- K3052
- Conditions
- Transesophageal Echocardiography
- Keywords
- Transesophageal Echocardiography, Surgery, Rescue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jul 2023 (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.
We initiate this study to assess the diagnostic efficiency of PReTEE, a simplified TEE scan sequence with a combination of 3 valuable views of ME 4C, ME AV LAX and TG SAX, in identifying cardiac pathologies in the phase of difficult cardiopulmonary bypass separation among patients who will undergo high-risk cardiac surgical procedures.
Detailed description
There are 6 TEE operators who will participate in our trial, which is of restriction.
Also, the participants we scheme to include are all junior TEE operators at our institute, who have already skilled at images obtainment and interpretation. Prior to the trial initiation, all these TEE operators will be randomly assigned into either the PReTEE group or the conventional TEE group with a 1:1 ratio (3 per group). Due to another limitation of eligible patients, TEE examinations thereby for patients are not conducted by equal numbers of operators stratified by groups. Furthermore, patients will be examined by 1-4 operators and 1 expert without removing the probe when separated from cardiopulmonary bypass. The ultimate sample size we calculate is 46 TEE examinations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The PReTEE group | Experimental | Diagnostic Test: The PReTEE groupPrior to clinical application of PReTEE, all participants designated must receive professional training. Within the given 120 seconds participants in the PreTEE group need to provide the leading cause with regard to difficult separation from cardiopulmonary bypass among high-risk cardiac surgical procedures. |
| The conventional TEE group | Active comparator | Diagnostic Test: The conventional TEE groupThe routine intra-operative TEE examinations are performed within the given 120 seconds before patients are separated from the cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 yr and greater;
- High-risk cardiac surgery (one of the followings): Baseline left ventricular ejection fraction < 50%, Coronary artery bypass graft combined with valve procedures, Multiple valve procedures (≥ 2), Aortic root or arch involved, Euroscore > 6, Previous cardiovascular surgery
Key exclusion criteria (6 listed)
- Lack of patient consent;
- Esophageal pathology (stricture, tumor, perforation/laceration, ulcer or fistula, diverticulum);
- Hiatus hernia; Perforated viscus;
- Active/recent upper gastrointestinal (GI) bleed;
- Non-elective cardiac procedures;
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 |
|---|---|---|
| The PReTEE groupPrior to clinical application of PReTEE, all participants designated must receive professional training. They need to receive lectures focusing on the clinical thinking flowchart of rescue transesophageal echocardiography, in conjuntion with the simulator-based training. The discriminating ability of PReTEE will be further assessed in real clinical scenario, that is, within the specified 120 seconds participants in the PreTEE group need to provide the leading causes with regard to difficult separation from cardiopulmonary bypass in high-risk cardiac surgical procedures. All examinations will be supervised by a TEE expert owning to safety considerations but without help in views acquirement or interpretation. After completion of study assessments, the TEE expert will perform a standard comprehensive TEE, the results of which was reported to the attending cardiac anesthesiologist in charge of the patient and the recorders. | Diagnostic test | The PReTEE group |
| The conventional TEE groupBefore cardiopulmonary bypass separation, conventional TEE examinations will be performed within the specified 120 seconds. Then, the expert will also perform a standard comprehensive TEE; the leading cause should also be presented to the attending anesthesiologists and recorders. | Diagnostic test | The conventional TEE group |
Primary outcome
Time taken in seconds in seeking out the leading cause of difficult CPB separation.
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Time will be recorded in rea-time fashion from the appearance of midesophageal 4 chamber view to the diagnose of leading cause of difficult CPB separation in both the PReTEE group and the conventional group.
The rate of successful diagnosis.
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Following the completion of TEE assessment by operators in the PreTEE group or in the conventional TEE group, the TEE expert in our center will then perform a standard comprehensive examination. The TEE expert will also be required to provide the leading cause of difficult separation, which then be presented to the attending anesthesiologist and cardiac surgeons as the reference of therapeutic approaches. The successful diagnosis is defined as the agreement of cause between operators in the PreTEE group or in the conventional TEE group and the expert.
6 secondary outcomes
Detection rate of hypovolemia
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of left ventricular outflow tract obstruction
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of regional wall motion abnormality
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of left ventricular systolic dysfunction
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of right ventricular systolic dysfunction
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Detection rate of right ventricular outflow tract obstruction
Time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 39138581Wang C, Tian Y, Bai B, He K, Lu H, Yu C, Miao Q. Application of a simplified transesophageal echocardiography examination sequence in high-risk cardiac surgery. Trials. 2024 Aug 13;25(1):535. doi: 10.1186/s13063-024-08338-9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PReTEE group and The conventional TEE group in people with Transesophageal Echocardiography, run by Peking Union Medical College Hospital at 1 site 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 2 inclusion and 6 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Chunhua Yu, MD (13811585975, yuchuh@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken in seconds in seeking out the leading cause of difficult CPB separation. (time frame: From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05960552, which also lists 1 linked publication.
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 14 Aug 2023.