Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity...
Coronary; IschemicArrhythmias12 moreWith the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators...
CardiomyopathyCardiac Arrhythmia2 moreIf a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals to detect the presence of surgical sponges inside the body. The device is now being used routinely to make sure that no sponges are left inside a patient at the end of an operation. However, the RF device has not been implemented in procedures for patients with cardiac implantable electronic devices (CIEDs). While the device is FDA approved for use, there is a theoretical concern that the radiofrequency signals used to detect the sponges will change the settings on the pacemaker or the defibrillator. Changing the settings on a pacemaker might make it pace the heart too quickly or too slowly, while changing the settings on a defibrillator might cause unnecessary shocks or prevent it from shocking the heart if the patient were to have cardiac arrest. The purpose of this study is to test whether the radiofrequency device used to detect sponges can cause a clinically significant change to the settings on pacemakers and defibrillators. To minimize potential risk, the device will be tested only on patients who are having the pacemaker or defibrillator removed or replaced as part of their regular medical care, either because it is infected or because the battery has worn out. Before the pacemaker or defibrillator is removed, the settings will be carefully and completely recorded and the radiofrequency device will be used to scan the body for sponges as it would be done during normal operation. After the pacemaker or defibrillator is taken out, the settings will again be recorded and compared to the settings before the scan. In a standard device removal procedure, no clinically significant change in CIED settings would be expected. If a new pacemaker or defibrillator is implanted in the patient, it will not be exposed to the detection device at all. We will also test whether the RF device has any effect on temporary pacemakers that patients may receive after open heart surgery. We plan to perform testing in a total of 50 patients, 40 with permanent pacemakers or defibrillators and 10 with temporary pacemakers.
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered...
ArrhythmiaThe study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.
Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites
ArrhythmiaCardiacBioequivalence of propafenone hydrochloride capsules manufactured at two different sites
Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients
Ischaemic Heart DiseaseCardiac Arrhythmia1 moreThe objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component. The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual function.
Comparison of Dexmedetomidine and Remifentanil Infusion During CABG
Coronary Artery Bypass GraftHypokalemia3 moreWe are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.
Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions...
Cardiac ArrhythmiasAtrial Fibrillation1 moreIt's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring. These patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer. The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.
Platelet Transfusion During Neonatal Open Heart Surgery
Cardiac DiseaseCardiac Surgery5 moreHypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery. Background: What is the Problem? - Bleeding, Transfusion and Outcomes Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4 The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achieving hemostasis, it comes with significant effects on post CPB hemodynamics, constantly changing hematocrit, variable blood volume with inability to achieve steady state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary hypertension. Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has distinct advantages of reducing transfusions and improving outcomes.
Telemedicine Enabling Patients in Self-care Behaviors
ArrythmiaThe purpose of the study is to see if monthly telemedicine computer visits (visits using the computer) improve the time it takes to identify and treat an arrhythmia. The second purpose is to see if monthly telemedicine computer visits improves the participant's understanding of the arrhythmia and improves how the participant feels with daily activities.
Reveal® XT Performance Trial (XPECT)
Atrial FibrillationRisk of Cardiac ArrhythmiasThe purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.