Evaluating the learning curve of residents using flowmetry and ultrasound during heart surgery
Cardiac Surgery Residents' Learning Curve of Intraoperative Transit-time Flowmetry and High-frequency Ultrasound in Coronary Artery Bypass Surgery: the LEARNERS Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06589323
This study is trying to see how well heart surgery residents learn to use special tools to check the quality of grafts during heart surgery for patients getting bypass surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06589323 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the learning curve of cardiac surgery residents in using transit-time flowmetry (TTFM) and high-frequency ultrasound (HFUS) for evaluating graft quality during coronary artery bypass grafting (CABG). The study will enroll adult patients undergoing CABG and will collect data on their surgical procedures and intraoperative measurements. The primary goal is to understand the complexity involved in mastering these techniques, which are recommended but underused in practice. The study will last four months, including patient enrollment and data analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require surgical revascularization for coronary artery disease.
Not a fit: Patients who are not undergoing CABG surgery or do not have coronary artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the training of cardiac surgery residents, leading to improved patient outcomes in CABG procedures.
How similar studies have performed: While the use of TTFM and HFUS is recommended, this study is novel in its focus on the learning curve of residents using these techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years old; * Written informed consent; * Indication to CABG surgery (both "on-pump" and "off-pump"); * Stable angina, unstable angina or acute coronary syndrome without ST elevation (NSTEMI). Exclusion Criteria: * Age \>= 18 years old; * Written informed consent; * Indication to CABG surgery (both "on-pump" and "off-pump"); * Stable angina, unstable angina or acute coronary syndrome without ST elevation (NSTEMI).
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario "A. Gemelli" IRCCS — Roma, RM, Italy (RECRUITING)
Study contacts
- Principal investigator: Federico Cammertoni, Dr. — Fondazione Policlinico Universitario A. Gemelli, IRCCS
- Study coordinator: Federico Cammertoni, Dr.
- Email: federico.cammertoni@policlinicogemelli.it
- Phone: +393292060538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease