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Transesophageal Echocardiographic Monitoring for Selective Antegrade Cardioplegia: A Prospective Self-Controlled Before-After Study

Transesophageal Echocardiographic Monitoring for Selective Antegrade Cardioplegia: A Prospective Self-Controlled Before-After Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1010250057
Enrollment
53
Registered
2026-01-30
Start date
2026-02-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular surgery using cardiopulmonary bypass

Interventions

Monitoring of Selective Coronary Perfusion Using Transesophageal Echocardiography

Sponsors

Suda Yasuhiro
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo cardiac surgery using cardiopulmonary bypass 2. Patients scheduled to undergo selective antegrade cardioplegia 3. Patients aged 18 years or older at the time of consent acquisition 4. Patients for whom written consent has been obtained for participation in this study

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications for transesophageal echocardiography as listed below Esophageal stricture, esophageal varices (red color sign [RC] grade 1 or higher), esophageal diverticulum, post-gastric/esophageal surgery, esophageal cancer, bleeding/ulcers/tumors in the stomach or esophagus, history of neck/mediastinal radiation therapy, cervical spine injury, or other conditions requiring restricted neck mobility 2. Patients deemed unsuitable for the procedure by the attending physician

Design outcomes

Primary

MeasureTime frame
The frequency of perfusion failure during selective coronary perfusion, and the frequency of perfusion failure following monitoring by transesophageal echocardiography (improvement rate). If the improvement rate achieved through monitoring was not 100% (since statistical verification is unnecessary if improvement is possible with 100% probability), the exact McNemar test is used to verify whether the improvement in perfusion insufficiency through monitoring is statistically significant.

Secondary

MeasureTime frame
Cardioplegic circuit pressure and flow rate during infusion of cardiolegic solution Record values for left coronary artery only, simultaneous left and right (adding right coronary artery), when perfusion failure occurs, and when perfusion failure improves. Test for significant differences in circuit pressure and flow rate based on the presence or absence of perfusion failure. If normality is present, perform an independent t-test; if normality is absent, perform a Mann-Whitney U test and calculate the 95% confidence interval. When perfusion failure is resolved, record the cause of the failure if identified (e.g., catheter kinking, misidentification of the inlet, calcification at the coronary artery inlet or proximal segment).

Contacts

Public ContactYasuhiro Suda

Asahikawa Medical University

suda0223@asahikawa-med.ac.jp+81-166-68-2583

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026