Clinical trial NCT05960552: Perioperative Rescue Transesophageal Echocardiography in Intensive and Critical Status
Official title: Establishment and Verification of Clinical Thinking Flowchart of Rescue Transesophageal Echocardiography in the Diagnosis and Treatment of Perioperative Patients in Intensive and Critical Status
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transesophageal Echocardiography
Keywords: Transesophageal Echocardiography
Surgery
Rescue
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Time taken in seconds in seeking out the leading cause of difficult CPB separation.
timeFrame: 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.
measure: The rate of successful diagnosis.
timeFrame: 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:
measure: Detection rate of hypovolemia
timeFrame: 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.
measure: Detection rate of left ventricular outflow tract obstruction
timeFrame: 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.
measure: Detection rate of regional wall motion abnormality
timeFrame: 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.
measure: Detection rate of left ventricular systolic dysfunction
timeFrame: 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.
measure: Detection rate of right ventricular systolic dysfunction
timeFrame: 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.
measure: Detection rate of right ventricular outflow tract obstruction
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: