Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status

NCT05960552 | Unknown DMC

• 1 other identifier: K3052
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Transesophageal Echocardiography

Keywords

Transesophageal Echocardiography; Surgery; Rescue

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Diagnostic Test: The conventional TEE group

Interventions

The PReTEE group 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 PReTEE group

The conventional TEE group 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.

The conventional TEE group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39138581 DERIVED

Central Study Contacts

Chunhua Yu, MD

CONTACT

13811585975; yuchuh@pumch.cn

Chunrong Wang, MD

CONTACT

15811176696; emancipation258@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 25, 2023
• Study Start: August 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-07

Locations

CN (1)