Clinical Research Directory

Photobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting.

This randomized, double-blind clinical trial aims to evaluate the impact of photobiomodulation therapy on postoperative outcomes in patients undergoing coronary artery bypass grafting (CABG). The study will compare two techniques for saphenous vein graft harvesting: the conventional technique and the no-touch technique. Participants will be randomly allocated into four groups: conventional harvesting with sham laser, conventional harvesting with photobiomodulation, no-touch harvesting with sham laser, and no-touch harvesting with photobiomodulation. The primary objective is to evaluate the effects of photobiomodulation on wound healing and postoperative complications related to the saphenous vein harvesting site. Secondary outcomes include clinical outcomes and functional capacity after surgery. The results may contribute to improving postoperative recovery and optimizing surgical strategies in patients undergoing myocardial revascularization.

Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery

Postoperative pain following coronary artery bypass grafting (CABG) via median sternotomy remains a significant clinical problem and is associated with increased opioid consumption and postoperative complications. Fascial plane blocks have emerged as part of multimodal analgesia strategies in cardiac surgery. This prospective, randomized, controlled, single-blinded study aims to evaluate the effect of an induction-time multimodal fascial plane block package-consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block-on postoperative analgesia, opioid consumption, and clinical outcomes in patients undergoing elective isolated CABG with saphenous vein graft harvesting. Patients will be randomized in a 1:1 ratio to receive either the multimodal fascial plane block package in addition to standard postoperative analgesia or standard postoperative analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours. Secondary outcomes include pain scores, time to first opioid requirement, extubation time, postoperative pulmonary complications, atrial fibrillation, and length of ICU and hospital stay.

Investigation of the Effect of Prehabilitation Practice on Patient Outcomes in Frail Patients Planned for Elective Coronary Artery Bypass Graft

The basic concept of prehabilitation is to increase the functional capacity of the individual to withstand an expected injury. It embodies the idea of being proactive against the common reactive approach of rehabilitation. While the initial prehabilitation model was limited to physical training, it has now evolved into a multimodal entity that includes nutritional optimisation, psychosocial preparation and smoking cessation in addition to exercise programmes. In the last decade, there has been an increasing effort to coincide prehabilitation with surgery, as surgery is rightly perceived as a stressor for human structural and physiological functions.

Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting

The purpose of this prospective, randomized controlled clinical trial is to evaluate early postoperative outcomes and fluid drainage dynamics between continuous active negative-pressure chest drainage (-10 mmHg) and standard spontaneous closed underwater-seal drainage in adult patients undergoing elective isolated coronary artery bypass grafting (CABG).

Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy

This prospective, non-blinded, single-center, translational research study aims to validate a multimodal advanced imaging exam for cardiac viability. The protocol utilizes three distinct imaging modalities: Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), and Hyperpolarized Carbon-13 (HP-13C) Pyruvate Magnetic Resonance Imaging (MRI). Under this protocol, the SPECT MPI and FDG-PET exams will be used in combination to comprehensively assess myocardial viability. Concurrently, the HP-13C Pyruvate MRI will be utilized to provide additional insights into myocardial metabolism. The study will evaluate healthy volunteers to establish baseline parameters and patients with ischemic cardiomyopathy (ICM) before and after surgical revascularization.

Dexmedetomidine Medication Records and Delirium After Coronary Artery Bypass Grafting

This retrospective observational study uses de-identified electronic health records from the TriNetX Global Collaborative Network. The procedure eligibility period is 1 January 2010 through 1 July 2025. The primary analysis concerns adults with a recorded qualifying coronary artery bypass grafting (CABG) procedure. Valve-coded procedures are examined in a separately constructed and separately matched exploratory population. The populations may overlap and do not constitute independent replication cohorts. Patients are classified by the presence or absence of a dexmedetomidine medication record on the calendar day before or the day of the index procedure. This definition does not confirm administration, dose or intraday timing. The primary outcome is a qualifying delirium or disorientation code during days 1-30. Nine secondary endpoints concern mortality and selected recorded complications during days 0-30; eight are inferential and the prolonged-ventilation code endpoint is descriptive. An inpatient or observation encounter during days 1-30 is described separately and is not interpreted as readmission. Same-day records cannot establish whether an outcome preceded or followed exposure. No treatment is assigned by the investigators. Analyses use permitted aggregate outputs, without identifiable or row-level participant data. The clinical definitions were revised with knowledge of earlier analyses. CABG primary and F05-only outcomes were first rerun on 5 September 2026 and were seen before a technical amendment permitting automatic propensity-score rematching for each outcome batch and unavoidable comparative calculations accompanying descriptive patient counts. The approved eligibility, exposure and outcome windows, codes, covariates, category boundaries and eight-test multiplicity family were not changed by that technical amendment. Subsequent technical refreshes and their source versions are recorded separately. Neither the original registration nor this amendment is presented as prospective registration of the original analysis.

Incentive Spirometry Versus Inspiratory Muscle Training After Coronary Artery Bypass Grafting

This study will be conducted to compare between incentive spirometry verses inspiratory muscle training preoperatively on (ABG) after coronary artery bypass graft surgery. Is there any significant difference of preoperative incentive spirometry verses inspiratory muscle training on Arterial blood gases (ABG) after coronary artery bypass graft surgery? Participants will: Group A (incentive spirometry group ) Group B (Inspiratory muscle trainer group ) for 5 days before operative Group C (control group) and group a , b will have routinely postoperative

Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery

The goal of this clinical trial is to examine the effects of sensory and cognitive stimulation on physiological, psychological, and functional recovery in adult patients after cardiac surgery who are treated in the intensive care unit (ICU). The main questions it aims to answer are: * Does sensory and/or cognitive stimulation reduce anxiety and improve hemodynamic stability in ICU patients? * Does it enhance physical function and independence during early rehabilitation in the ICU? Researchers will compare four groups: 1. Standard care (control), 2. Cognitive stimulation, 3. Auditory stimulation (music), 4. Multisensory stimulation (touch + smell) to assess which intervention is most effective in improving recovery parameters. Participants will: * Be randomly assigned to one of four groups during early mobilization in the ICU * Receive a 30-minute intervention session depending on group assignment * Be evaluated for heart rate, blood pressure, oxygen saturation, anxiety (VAS), physical function (PFIT, FIM), and satisfaction before and after the session

Effects of Emotional Freedom Techniques on Pain, Cardiac Anxiety, and Sleep Quality in Coronary Artery Bypass Grafting

Objective: To determine the effect of Emotional Freedom Techniques (EFT) on pain, cardiac anxiety and sleep quality in patients undergoing Coronary Artery Bypass Graft (CABG) surgery. Materials and Methods: The study will be conducted between 2025 and 2026 as a pretest-posttest, parallel design (1:1) randomized controlled trial. The study population will consist of patients undergoing coronary artery bypass grafting (CABG) at the Kütahya City Hospital Cardiovascular Surgery Department. The sample size was determined to be 66 patients, with 33 patients each in the experimental and control groups. Measurement tools include a Personal Information Form, Visual Analog Scale (VAS), Cardiac Anxiety Scale, and Richard Campbell Sleep Scale. Data will be collected through one-on-one patient interviews. The researcher has successfully completed a 3.5-hour EFT training program at the Boğaziçi Education Institute. EFT will be administered to the patients by the researcher. Patients undergoing coronary artery bypass graft surgery at the Cardiovascular Surgery Clinic who volunteer to participate in the study and meet the inclusion criteria will complete the Informed Consent Form, Personal Information Form, Visual Analogue Scale (VAS), Cardiac Anxiety Scale, and Richard-Campbell Sleep Scale. Patients will then be assigned to the experimental or control groups by a person other than the researcher based on the randomization list. Patients in the experimental group will receive EFT in addition to standard cardiovascular surgery clinic procedures, while patients in the control group will receive standard cardiovascular surgery clinic procedures. Data analysis will be conducted using SPSS. The study will be conducted in accordance with the principles of the Declaration of Helsinki. Findings: The findings of the research will be written after the data to be obtained after the implementation of the research and data collection will be analyzed in the SPSS program. Conclusion: The results of the research will be written by determining the findings after analyzing the data to be obtained after the implementation of the research and data collection in the SPSS program.

Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients

Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced quality of life. Although minimally invasive coronary surgery (MICS) through left minithoracotomy has been associated with reduced surgical trauma and faster recovery in selected patients, its benefits have not been evaluated in a randomized trial specifically involving frail patients. The MINI FRAGILE trial is a prospective, multicenter, randomized, open-label clinical trial designed to compare minimally invasive CABG performed through left anterior minithoracotomy with conventional median sternotomy in patients aged 60 years or older with pre-frailty or frailty undergoing surgical coronary revascularization. Eligible participants will be randomized in a 1:1 ratio to either surgical approach. The primary objective is to determine whether minimally invasive CABG improves functional recovery, assessed by the change in the physical component of the SF-36 Health Survey 30 days after surgery. Secondary outcomes include major adverse cardiovascular events, mortality, intensive care unit and hospital length of stay, duration of mechanical ventilation, return to usual activities, surgical site infection, perioperative complications, postoperative pain, readmission, and adherence to enhanced recovery measures. The results of this trial are expected to provide high-quality evidence regarding the optimal surgical approach for frail patients requiring coronary artery bypass grafting.

Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in Postoperative Pain Management After Coronary Artery Bypass Grafting

Coronary Artery Bypass Grafting (CABG) is a common surgical procedure for ischemic heart disease, but it often leads to severe acute and chronic postoperative pain, which can delay recovery and reduce patient comfort. Effective pain management is crucial to prevent pulmonary complications and long hospital stays. Peripheral nerve blocks are increasingly used to reduce opioid consumption and improve patient satisfaction after major surgery. This prospective, observational study aims to compare the effectiveness and safety of two different regional anesthesia techniques, the Erector Spinae Plane Block (ESPB) and the Serratus Posterior Superior Intercostal Plane Block (SPSIPB), in managing postoperative pain in patients undergoing CABG via median sternotomy. Patients aged 18-80 years, classified as ASA II-III, who are scheduled for elective CABG will be included. The choice of block technique (ESPB or SPSIPB) will be determined by the operating anesthesiologist based on the visibility of anatomical structures (transverse processes) under ultrasound guidance. All patients will receive the same general anesthesia and be managed postoperatively with Intravenous Patient-Controlled Analgesia (PCA). The main goal is to determine which block provides optimal pain control, measured by the time to first rescue analgesia and pain scores (NRS) at various time points after extubation. Secondary outcomes include intraoperative opioid consumption, total PCA usage, extubation time, and the incidence of opioid-related side effects. The findings will help optimize pain protocols for cardiac surgery patients.

Chest Tube-Delivered Bupivacaine to Decrease Postoperative Pain After Cardiac Surgery

Background: After heart surgery, patients require temporary chest tubes - plastic drains placed inside the chest to prevent fluid building up around the heart and lungs. These tubes are often very painful and can limit breathing, coughing, and movement, which necessitates usage of painkiller medication (opioids and non-steroidal anti-inflammatory drugs (NSAIDs)) that have negative side effects and can prolong hospital recovery. Despite this common problem, routine care lacks simple, add-on strategies that directly numb pain at the chest tube sites rather than relying solely on whole-body painkiller medicine. Purpose: To determine whether injecting a long-acting numbing medicine (bupivacaine 0.5%) through chest tubes safely reduces pain and lowers opioid and NSAID use compared with placebo. Objective: With ethics approval, data access, and study procedures already in place before May, the specific objective for this studentship is to collect and analyze data to evaluate the short-term effect of bupivacaine versus placebo on: * Mean pain scores from initial recovery to chest tube removal * Total mean opioid and NSAID use Methods: This single-centre, 1:1 block randomized, double-blind, placebo-controlled trial will enroll 60 adults undergoing coronary artery bypass (procedure to bypass blocked blood vessels supplying heart muscle using healthy blood vessels) at the Foothills Medical Centre. Patients receive either 10 mL bupivacaine 0.5% or normal saline (saltwater placebo) through chest tubes by heart surgeons whenever pain hits ≥3/10 using the Numeric Rating Scale (0 = no pain; 10 = most intense pain), from initial recovery to chest tube removal. Standard pain care will continue for all patients. The study team will record pain scores, opioid and NSAID doses, and any side effects for each group. Interval pain reduction will be measured 30, 60, 120 and 240 minutes post injection. Mean pain reduction and total painkiller use will be compared between the two groups.

Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG

To explore surgical strategies that reduce perioperative neurologic complications in cardiovascular surgery, with the aim of improving perioperative outcomes and quality of life while reducing the socioeconomic burden. Specifically: This multicenter, randomized controlled clinical trial will evaluate the benefits of a novel aortic no-touch technique in reducing perioperative silent brain infarction(SBI) among patients undergoing surgical treatment for coronary artery disease. The findings are expected to provide a safe and effective myocardial revascularization strategy for individuals at high risk of cerebral ischemia.

Effect of Cardiovascular Autonomic Neuropathy on AKI and Outcomes in Isolated CABG Surgery

This study aims to investigate the effects of Cardiovascular Autonomic Neuropathy (CAN) on Acute Kidney Injury (AKI) and clinical outcomes in patients undergoing isolated Coronary Artery Bypass Graft (CABG) surgery requiring extracorporeal circulation(ECC). Preoperative data including demographics, comorbidities, kidney function tests, hemodynamic parameters, and baseline regional cerebral oxygen saturation (rSO2) will be recorded. Intraoperative data will include hemodynamics, urine output, blood gases, cardiopulmonary bypass and aortic cross-clamp times, cardioplegia details, number of coronary anastomoses, and rSO2 changes at defined time points. Postoperatively, kidney function, neurological status, mechanical ventilation duration, inotropic drug use, transfusion requirements, complications, ICU and hospital length of stay, and mortality will be evaluated. Acute Kidney Injury will be classified according to KDIGO criteria. The primary objective is to analyze the effect of CAN on AKI. Secondary objectives include assessing the impact of CAN on other clinical outcomes and exploring the relationship between CAN and intraoperative cerebral oxygen changes. This study has been approved by the Acıbadem University and Acıbadem Healthcare Institutions Medical Research Ethics Committee (ATADEK) and will be conducted following ethical principles and good clinical practice.

Metabolic Profile and Tissue Perfusion in Patients Undergoing Open Heart Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion.

Effects of a Recovery-Promoting Program in Patients Undergoing CABG Surgery

Patients undergoing coronary artery bypass graft (CABG) surgery often experience physical limitations, psychological stress, and challenges during recovery after hospital discharge. Inadequate preparation and limited follow-up support may affect patients' confidence in self-care and overall recovery. The purpose of this study is to evaluate the effects of a recovery-promoting program on self-efficacy, quality of recovery, and clinical outcomes in patients undergoing CABG surgery. Participants will receive standard postoperative care. In addition, participants in the intervention group will receive a recovery-promoting program provided by nurses, which includes structured education, guidance on postoperative activity and symptom management, and follow-up support after discharge. The study will assess changes in self-efficacy, quality of recovery, and selected clinical outcomes to compare recovery between participants who receive the recovery-promoting program and those who receive standard care.

Saudi CABG Audit and Registry

The Saudi CABG Audit and Registry (SCAR) is a prospective, multicenter national clinical quality registry designed to systematically collect perioperative and long-term outcome data for all patients undergoing coronary artery bypass grafting (CABG) in Saudi Arabia. The registry will begin with a pilot phase in selected tertiary cardiac centers and will progressively expand to national coverage. SCAR captures detailed information on patient demographics, cardiac status, operative techniques, postoperative outcomes, and 1-year follow-up, including patient-reported quality-of-life measures (EQ-5D and SF-36). The aim is to establish a standardized national platform for benchmarking, quality improvement, and real-world evidence generation to support clinical decision-making and health policy development in cardiac surgery. Data are collected prospectively through secure electronic systems, anonymized before central storage, and analyzed using standardized definitions aligned with international registries such as STS and E-CABG.

Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery

A review of the literature suggests that high-intensity intermittent inspiratory muscle training (IMT) combined with the Otago exercise program may provide positive effects on early post-discharge recovery of patients aged 65 years and older undergoing coronary artery bypass graft (CABG) surgery. No studies have yet examined the effects of high-intensity intermittent IMT combined with the Otago exercise program on patients undergoing CABG surgery. This study is the first to evaluate the effects of high-intensity intermittent IMT combined with the Otago exercise program on pulmonary function, functional capacity, muscle strength, functional mobility, balance, anxiety and depression levels, frailty, and quality of life in elderly patients undergoing CABG surgery.