Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Transesophageal Echocardiography

Treatments: Diagnostic Test: The PReTEE group; Diagnostic Test: The conventional TEE group

Study type: Interventional

Funder types: Other

Identifiers

NCT05960552

K3052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

The PReTEE group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: The PReTEE group

The conventional TEE group

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: The conventional TEE group