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Cardiac Surgery clinical trials

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NCT ID: NCT06071039 Completed - Cardiac Surgery Clinical Trials

Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

In this study, researchers developed a mattress made of 3D spacer fabric to relieve pressure during cardiovascular surgery. Following the development process, an initial assessment of the mattress's effectiveness was carried out on healthy volunteers. The same people lay first on the developed product and then on the surgical mattress in the supine position. In both cases, the pressure between the person and the mattress was measured using a force-sensitive resistor (using Interlink's FRS-406 series sensors). Thirty patients were included in the initial evaluation. A randomised controlled trial was then carried out with patients undergoing surgery (patients were divided into two groups; (a) mattress developed by the researchers and (b) standard operating theatre mattress). Sixty patients were divided into two groups using block randomisation. In the block randomisation, patients below or above body mass index 27 were equally distributed between the groups. Pressure levels were measured continuously during surgery using the same sensors.

NCT ID: NCT06030115 Completed - Cardiac Surgery Clinical Trials

Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

Start date: July 1, 2019
Phase:
Study type: Observational

Determine if the standard of care at a cardiac rehabilitation center using what the investigators term to be "hybrid model" on the exercise component of cardiac rehabilitation is associated with improved adherence and outcomes. Discuss the hybrid model in comparison to traditional cardiac rehabilitation and layout a template on how to incorporate this hybrid model. Discuss factors that may lead to poor adherence and attendance to cardiac rehabilitation.

NCT ID: NCT06021587 Recruiting - Cardiac Surgery Clinical Trials

Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction

LevoCV
Start date: July 1, 2023
Phase:
Study type: Observational

Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.

NCT ID: NCT06012760 Recruiting - Anemia Clinical Trials

The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

CIPAT
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Previous studies have shown that perioperative intravenous iron has a beneficial effect on patients with perioperative anaemia. To assess whether a combined iron supplementation regimen can reduce perioperative allogeneic blood transfusions in patients with iron deficiency anaemia undergoing major cardiac surgery under haemodynamic anaesthesia, a multicentre randomised clinical trial (CIPAT study) will be conducted. In the CIPAT study, patients undergoing elective major cardiac surgery under general anaesthesia will be randomly allocated to a control group and a combined iron supplementation group. Patients in the combined iron supplementation group will receive a combination iron supplementation regimen of iron sucrose in combination with Human Erythropoietin and vitamin C three times in the week prior to surgery, while patients in the control group will receive the same dose of placebo three times in the week prior to surgery. The primary endpoint is the volume of allogeneic erythrocyte infusion from the start of surgery to 5 days postoperatively. It is hypothesised that patients in the combined iron supplementation group will have fewer perioperative allogeneic red blood cell transfusions than those in the control group.

NCT ID: NCT05984563 Not yet recruiting - Cardiac Surgery Clinical Trials

Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass

OPTI-DO2
Start date: August 1, 2023
Phase:
Study type: Observational

Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output, hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in unpredictable, and the other factors influencing DO2 interindividual variability are not known. Moreover, the relation between DO2 and tissue perfusion is not well established, as DO2 requirement could differ between individuals or organs. Population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2 variability during CPB and develop a model to optimize GDP strategy.

NCT ID: NCT05957003 Recruiting - Clinical trials for Postoperative Complications

Fluid Responsiveness in Post-cardiac Surgery

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

NCT ID: NCT05944146 Recruiting - Cardiac Surgery Clinical Trials

Consistency of Carotid Doppler Blood Flow and Thermodilution Technique

Start date: May 31, 2023
Phase: N/A
Study type: Interventional

Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.

NCT ID: NCT05936944 Recruiting - Cardiac Surgery Clinical Trials

Role of Natural Light in the Prevention of Delirium After Cardiac Surgery: a Prospective Observational Study With Historical Control

iWOnDer
Start date: June 14, 2023
Phase:
Study type: Observational

Postoperative delirium is a common complication that usually occurs acutely within the first 24 hours after surgery and resolves within 72 hours; it is common in all medical areas and particularly affects patients over the age of 65 and those with pre-existing cognitive impairments. It is characterized by difficulty organizing and coordinating thoughts and by slowing down motor functions that are observed for a short period after surgery. The study will be an observational prospective study with historical control (pre/post-study) whose primary objective is to identify the incidence of postoperative delirium in patients undergoing cardiac surgery. The population will be adult patients undergoing cardiac surgery at our University Hospital over a period of 12 months. The intervention will be exposure to totally artificial light (for patients hospitalized after the relocation of the department to its original location). The comparator will be exposure to natural light (for patients who will be hospitalized during our temporary transfer to an environment with natural lighting). The outcome will be the incidence of delirium, measured with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale; episodes of agitation requiring sedative drugs; time elapsed before onset of delirium. The study will last 12 months.

NCT ID: NCT05932394 Completed - Delirium Clinical Trials

Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

VisualMaterial
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

The aim is to evaluate the impact of visual projection of images of relatives or loved ones in patients undergoing cardiac surgery in the immediate postoperative period, and its influence on the incidence and development of postoperative delirium. A randomized, double-blind clinical trial was designed in the immediate postoperative period of adult patients undergoing cardiac surgery. CONSORT guidelines were followed. A control group and an intervention group were established. In the intervention group, the patients underwent a visual projection, while the usual unit treatment was carried out with the control group. Sociodemographic, anthropometric, anesthetic, and surgical variables were also recorded. The postoperative delirium assessment scale used was the "Confusion Assessment Method for the Intensive Care Unit scale" (CAM-ICU). The projection of visual material could reduce the incidence of postoperative delirium in patients undergoing cardiac surgery, although it cannot be established that it is effective as a treatment once the pathology is already established. The results obtained suggest that the visual projection of images is an effective and economical tool to address an increasingly incidental problem due to the aging of the population.

NCT ID: NCT05914090 Not yet recruiting - Cardiac Surgery Clinical Trials

The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult

Start date: October 11, 2023
Phase: N/A
Study type: Interventional

Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACCE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.