Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status

Not Applicable

Recruiting

• Conditions: Transesophageal Echocardiography
• Interventions: Diagnostic Test: The conventional TEE group; Diagnostic Test: The PReTEE group

• Registration Number: NCT05960552
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-25
• Study Start: 2023-08-01
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The conventional TEE group	The conventional TEE group	The routine intra-operative TEE examinations are performed within the given 120 seconds before patients are separated from the cardiopulmonary bypass.
The PReTEE group	The PReTEE group	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China