Transesophageal Echocardiography
Conditions
Keywords
Transesophageal Echocardiography, Surgery, Rescue
Brief 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 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.
Interventions
DIAGNOSTIC_TESTThe PReTEE group
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.
DIAGNOSTIC_TESTThe conventional TEE group
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age of 18 yr and greater; 2. 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
Exclusion criteria
1. Lack of patient consent; 2. Esophageal pathology (stricture, tumor, perforation/laceration, ulcer or fistula, diverticulum); 3. Hiatus hernia; Perforated viscus; 4. Active/recent upper gastrointestinal (GI) bleed; 5. Non-elective cardiac procedures; 6. Preoperative mechanical cardiac support (ECMO, LVAD or IABP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time taken in seconds in seeking out the leading cause of difficult CPB separation. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of regional wall motion abnormality | 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. | 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 |
| Detection rate of left ventricular systolic dysfunction | 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. | Left ventricular systolic dysfunction can be assessed as a reduction in systolic function and an increase in diastolic dimension. |
| Detection rate of hypovolemia | 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. | Reduction in the LV cavity indicates hypovolemia. |
| Detection rate of right ventricular outflow tract obstruction | 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 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. |
| Detection rate of right ventricular systolic dysfunction | 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. | A TEE with a D-shaped LV on trans-gastric short axis view is suggestive of RV volume overload and systolic dysfunction |
| Detection rate of left ventricular outflow tract obstruction | 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 occurrence of SAM |
Countries
China
Contacts
Primary ContactChunhua Yu, MD
Backup ContactChunrong Wang, MD
Outcome results
None listed