Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status

NCT ID: NCT05960552

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-12-31

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.

Conditions

Transesophageal Echocardiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

The PReTEE group

Intervention Type: DIAGNOSTIC_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 group

The routine intra-operative TEE examinations are performed within the given 120 seconds before patients are separated from the cardiopulmonary bypass.

Group Type: ACTIVE_COMPARATOR

The conventional TEE group

Intervention Type: DIAGNOSTIC_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.

Interventions

The 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.

Intervention Type: DIAGNOSTIC_TEST

The 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunhua Yu, MD

Role: CONTACT

yuchuh@pumch.cn

13811585975

Chunrong Wang, MD

Role: CONTACT

emancipation258@outlook.com

15811176696

Facility Contacts

Chunrong Wang, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39138581 (View on PubMed)

Other Identifiers

K3052

Identifier Type: -

Identifier Source: org_study_id