JRCT ID: jRCT1010250057
Registered date:30/01/2026
Transesophageal Echocardiographic Monitoring for Selective Antegrade Cardioplegia: A Prospective Self-Controlled Before-After Study
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Cardiovascular surgery using cardiopulmonary bypass |
| Date of first enrollment | 17/02/2026 |
| Target sample size | 53 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Monitoring of Selective Coronary Perfusion Using Transesophageal Echocardiography |
Outcome(s)
| Primary Outcome | 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 Outcome | 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). |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | |
| Include 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 |
| Exclude 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 |
Related Information
| Primary Sponsor | Suda Yasuhiro |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yasuhiro Suda |
| Address | Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan Hokkaido Japan 078-8510 |
| Telephone | +81-166-68-2583 |
| suda0223@asahikawa-med.ac.jp | |
| Affiliation | Asahikawa Medical University |
| Scientific contact | |
| Name | Yasuhiro Suda |
| Address | Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan Hokkaido Japan 078-8510 |
| Telephone | +81-166-68-2583 |
| suda0223@asahikawa-med.ac.jp | |
| Affiliation | Asahikawa Medical University |