Clinical Research Directory

Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB

Enhanced recovery after surgery protocols aim to optimize perioperative care and improve surgical outcomes. Preoperative carbohydrate loading has demonstrated benefits in reducing insulin resistance and improving patient outcomes. While non-diabetic patients benefit from this approach, its efficacy in diabetic type 2 patients undergoing CABG remains less understood. This study aims to address this gab by evaluating the physiological and clinical outcomes for carbohydrate loading in this specific population.

Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units

The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).

Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group). The results will be compared for non-inferiority with those obtained using the control group cannulas.

Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

This study aims to learn more about blood management in children undergoing heart surgery, such as the right amounts, and the best blood products, to administer. It also aims to develop a mathematical model that may help researchers better predict and treat patients who need blood transfusions during heart surgery.

Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery

This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. It is a single-center, prospective, randomized trial that will include 60 patients aged 16 to 40 undergoing surgeries such as valve replacements, pulmonary decortication, thoracic sympathectomies, and video-assisted thoracic procedures. Patients will be randomized into three groups: Group 1: Standard anesthesia protocol combined with interactive VR therapy using games like Fruit Ninja 2, Beat Saber, and Oculus First Contact, as well as passive contemplation of immersive virtual environments (Blue Planet, Wander). Group 2: Standard anesthesia protocol combined with VR therapy focusing solely on passive imagery, such as immersive 360° videos available on YouTube VR. Group 3 (Control): Standard anesthesia protocol without any VR intervention. The VR intervention will occur in three daily sessions lasting 30-45 minutes each, over the first five postoperative days or until hospital discharge, whichever comes first. Training in VR equipment usage and full supervision by the study team will be provided throughout all sessions. Primary Objective: The primary goal is to reduce total opioid consumption, measured through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Pain control will be assessed using the Visual Analogue Scale (VAS). Secondary Objectives: Evaluate the incidence of postoperative nausea and vomiting (PONV). Measure the duration of mechanical and non-invasive ventilation. Assess the length of stay in the ICU and the total hospital stay. Record the occurrence of paralytic ileus. Evaluate patient satisfaction. Assess cognitive status using the Mini-Mental State Examination (MMSE). Rationale: Postoperative pain following cardiac and thoracic surgeries is commonly treated with opioids, which are associated with adverse effects such as respiratory depression, nausea, vomiting, constipation, and risk of dependency. Virtual reality offers an innovative approach to pain management by creating immersive environments that serve as cognitive distractions. This immersive distraction modulates pain perception, reduces anxiety, and enhances overall well-being. Prior studies have shown that VR can effectively reduce pain perception and improve patient satisfaction, supporting its potential as a non-pharmacological adjunct in various clinical contexts. Methods: Participants will undergo standardized surgical and anesthetic protocols at the Instituto do Coração (InCor) of the Hospital das Clínicas at the University of São Paulo. Clinical and demographic data will be collected, including opioid consumption, VAS pain scores, ventilatory parameters, and other relevant recovery indicators. Statistical analyses will include descriptive statistics, univariate comparisons, and multivariate logistic regression to identify significant associations between the interventions and outcomes. Analyses will be performed using SPSS, with statistical significance set at p \< 0.05. Anticipated Outcomes: The study anticipates that VR will significantly reduce postoperative opioid consumption, enhance pain control, and improve patient satisfaction. Additionally, patients exposed to VR may experience shorter hospital stays, reduced side effects, and better overall recovery metrics. If proven effective, VR could serve as a scalable, cost-effective, and safe complement to traditional postoperative pain management strategies, especially in populations where minimizing opioid use is a clinical priority. Ethical Considerations:

Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)

This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). The primary outcome is total perioperative and postoperative opioid consumption. Secondary outcomes include postoperative pain scores (NRS), opioid-related side effects, block-related complications, and ICU stay duration.

Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

The most common cardiac surgeries are myocardial revascularization and valve replacement or plastic surgery. In the postoperative period of cardiac surgeries, the incidence of pulmonary complications ranges from 30% to 50% and is associated with increased length of hospital stay and morbidity and mortality. To reduce or minimize the occurrence of these complications, respiratory physiotherapy employs positive pressure reexpansion therapies, such as continuous positive airway pressure (CPAP) and positive pressure support with positive end-expiratory pressure (PS+PEEP). The goal of this clinical trial is to compare the effects of two positive pressure therapies, CPAP versus PS+PEEP, on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery, with mild to moderate pulmonary dysfunction. The main question it aims to answer is: Do patients in the immediate postoperative period of myocardial revascularization or valve replacement/plastic surgery, exhibiting mild to moderate pulmonary dysfunction, experience a comparable reversal of pulmonary conditions when treated with PS+PEEP versus CPAP? Participants will undergo the following assessments: spirometry, respiratory muscle strength testing, handgrip strength testing, and electrical impedance tomography. In the immediate postoperative period, participants will be randomized into two treatment groups: • Control Group PS+PEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94%; • Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.

Mandala Coloring and Its Effect on Anxiety and Depression Before Open Heart Surgery

This study was conducted to determine the Effect of Mandala Coloring on Anxiety and Depression Before Open Heart Surgery. This was a randomized, controlled experimental study. The sample comprised 84 patients who underwent open heart surgery (control: 41; experimental: 43). Eight pre-selected mandala drawings will be printed on separate A4 (21.0 cm × 29.7 cm) papers. After the patients are admitted to the hospital for the surgery process, the patients in the experimental group will be provided with at least 2 hours of mandala coloring per day until the day of their surgery. No intervention will be applied to the control group patients.

Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

The goal of this prospective observational study is to evaluate the most appropriate anticoagulation monitoring tool for unfractionated heparin (UFH), by comparison of different monitoring modalities in relation to adverse events occurrence (thrombosis/bleeding). The main study questions are: * What is the most appropriate anticoagulation monitoring tool (ACT, aPTT, viscoelastic tests (ROTEM), and anti-Xa) for UFH * What is the incidence of adverse events associated with anticoagulation and inflammation after heart and vascular interventions * Is there an association of available anticoagulation thresholds and monitoring tests with bleeding and/or thrombosis occurrence * Is there an association of inflammation with delirium Secondary study objectives include: * Association of anticoagulation levels as measured by ACT, aPTT, viscoelastic tests (ROTEM), and anti-factor-Xa with adverse events * Correlation of each anticoagulation monitoring test with the UFH anti-Xa measurement * Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa) and the amount of blood loss post surgery * The incidence of UFH-rebound effect and the need for protamine application * Association of inflammation and increased / reduced need for anticoagulation titration * Correlation of anticoagulation dosing with anticoagulation monitoring tests and adverse events * The association of inflammation with adverse events * The association and impact of inflammation on measured levels of anticoagulation with available tests * Influence of anticoagulation on mortality * Incidence of ECMO support * Incidence of delirium (hypoactive and hyperactive) and correlation with vital (newly onset postoperative atrial fibrillation amongst others) and laboratory parameters, including, and pre-existing neurological disorders

Study of the Relationship Between the Oxygenation State and Lung Ultrasound Score in Cardiac Surgery

After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Currently, lung ultrasound is little used in physiotherapy and no study explains the link between the lung ultrasound results and oxygenation patient state. Before considering the interest of lung ultrasound score as a criterion of effectiveness of a physiotherapy treatment through future studies, it is first important to objectivize the existence of a relationship between lung ultrasound score and the PaO2/FiO2 ratio after cardiac surgery. Lung ultrasound could provide direct clinical information without having to resort to other more invasive examinations to objectify the improvement of the patient's oxygenation. Main objective To show that the relative change in the PaO2/FiO2 ratio correlates with the change in lung ultrasound score measured in the short term between the beginning and the end of the first physiotherapy session associated with non invasive ventilation the day after surgery in cardiac patients Secondary objectives * To study the inter-operator (2 readers) reproducibility of the lung ultrasound score measurement. * To study the relationship between the relative variation of the PaO2/FiO2 ratio and the variation of each of the 12 zones of the lung ultrasound score * To Study the relationship between the initial lung ultrasound score and the relative variation of the PaO2/FiO2 ratio * To study the relative variation of the PaCO2 and the variation of the lung ultrasound score between the beginning and the end of the first session of physiotherapy management associated with NIV * To obtain from the patient in the short term feedback on his or her understanding of the explanations about lung ultrasound score provided by the physiotherapist during the session

The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure. Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3. Participants in the control group will be treated with conventional post-operative care.

Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease

The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.