Clinical Research Directory

Vagus Nerve Stimulation for Autonomic Modulation After Coronary Artery Bypass Graft Surgery

The objective of this randomized clinical trial is to investigate whether transcutaneous auricular vagus nerve stimulation (taVNS) can improve the recovery of patients undergoing coronary artery bypass grafting (CABG) through autonomic modulation, while also evaluating the safety of the intervention. The main questions this study aims to answer are: * Does taVNS improve autonomic modulation, as assessed by heart rate variability, in patients undergoing CABG? * Does taVNS reduce the inflammatory response and pain intensity while improving quality of life and functional capacity during the postoperative period? * Is taVNS a safe and well-tolerated intervention during recovery after CABG? The researchers will compare taVNS with a control group (sham stimulation/placebo) to determine whether the intervention leads to better clinical and functional outcomes in patients undergoing coronary artery bypass grafting. Participants will: * Receive sessions of transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation (placebo), according to the study randomization. * Undergo assessments of autonomic modulation using heart rate variability before and after the intervention. * Be evaluated for inflammatory markers, pain intensity, quality of life, and functional capacity at different time points during the postoperative period.

ESPB vs SPSIP for Postoperative Analgesia After CABG

This prospective, randomized, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA I-III) undergoing elective coronary artery bypass graft surgery. The primary outcome is postoperative pain intensity assessed by Numeric Rating Scale (NRS) at 2, 4, 8, 16, 24, and 48 hours after surgery. Secondary outcomes include intraoperative fentanyl/remifentanil consumption, postoperative morphine consumption, patient-controlled analgesia (PCA) demand/delivery parameters (if PCA is used), need for rescue analgesics, extubation and mobilization times, peak inspiratory flow measured by incentive spirometry at predefined time points, ICU and hospital length of stay, recovery quality (QoR-15 at 0, 24, and 48 hours), mortality, and block-related adverse events.

From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery

Prehab2Rehab is a prospective single-arm feasibility study evaluating the implementation of a multimodal, digitally supported prehabilitation program for adults awaiting elective cardiac surgery. During the routine preoperative waiting period, participants receive individualized education, psychosocial support, nutritional counselling, home-based physical activity guidance, and digital self-management support. The study aims to determine the feasibility, acceptability, usability, and safety of integrating this multidisciplinary prehabilitation pathway into routine clinical care. Exploratory outcomes include functional capacity, psychological well-being, nutritional status, digital engagement, and selected perioperative clinical outcomes to inform the design of future confirmatory trials.

Impact of Different Cardioplegia Solutions on Indicators of Myocardial Injury During Coronary Surgery

The aim of the present study is to investigate intra-operative changes in markers of myocardial injury during ischemia and reperfusion, comparing three methods of myocardial protection; St. Thomas' cold crystalloid cardioplegia, Calafiore warm blood cardioplegia, or modified del Nido cold blood cardioplegia in routine coronary artery bypass grafting procedures.

A Study Testing the Elana Device for Multi-Artery Heart Bypass Surgery

The purpose of the trial is to evaluate the feasibility and safety of multiple Elana Anastomotic Systems to anastomose multiple arterial grafts during coronary artery bypass grafting (CABG). In the first trial performed with the Elana Anastomotic System, the SAFE-CAB trial, only a single anastomosis with the left internal mammary artery (LIMA) was created with the system to the left anterior descending (LAD) coronary artery or a large Diagonal side-branch of the LAD. This is the most important bypass for patients, often described as the anastomosis that guarantees the survival of patients. However, often multiple anastomoses need to be created during bypass surgery. In the previous study, those anastomoses were performed using vein grafts with standard-of-care hand-sewn techniques. A large body of evidence exists indicating that arterial grafts provide better long-term outcomes for patients undergoing CABG procedures, mainly using the right internal mammary artery (RIMA), but also the Radial Artery, for anastomosis to the Circumflex (Cx) artery and sometimes the Right Coronary Artery. With assurance of safety and effectiveness of the Elena Anastomotic System for LIMA-to-LAD anastomoses and the similarity of the LIMA-to-LAD anastomosis to other arterial anastomoses (e.g., RIMA-to-Cx and RA-to-RCA) as a result of similar vessel diameters and anatomical features, the Elana Anastomotic System is considered to be suitable for multi-arterial bypass procedures. Therefore, this study aims to expand on the evidence of using the Elana Anastomotic System in a more complete multi-arterial CABG operation, where two or three anastomoses will be created with the Elana Anastomotic System in order to present a more comprehensive solution.