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Heart Surgery clinical trials

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NCT ID: NCT06373627 Not yet recruiting - Clinical trials for Congenital Heart Disease

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

PEACE-HYPNO
Start date: May 2, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06222866 Not yet recruiting - Delirium Clinical Trials

Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

PAC-AIM
Start date: March 1, 2024
Phase:
Study type: Observational

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

NCT ID: NCT06201117 Recruiting - Heart Surgery Clinical Trials

Effects of Preparatory Information on Anxiety and Treatment Adherence in Heart Surgery Patients

Start date: December 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effects of providing information to prepare for ICU stay in patients after heart surgery on anxiety and cooperative behaviors. The main questions it aims to answer are: - Are the anxiety levels before and after receiving prepared information video (VDO) and usual information different among participants in the experimental group? - Are the anxiety levels between participants who received prepared information VDO and usual information and usual information only different? - Are the cooperative behaviors during a recovery period in the ICU between participants who received prepared information VDO and usual information and usual information only different? The researcher will provide the prepared information for ICU stay through 12-minutes VDO, 2 times before the surgery to the experimental group in addition to the usual pre-operative information (usual care). Participants in the comparison group will receive usual pre-operative information only to see if the anxiety and cooperative behaviors during a recovery period in the ICU differ between the groups.

NCT ID: NCT06001502 Recruiting - Post Operative Pain Clinical Trials

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

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

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.

NCT ID: NCT05470686 Recruiting - Heart Surgery Clinical Trials

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

PaFiKinESAP
Start date: June 21, 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05402826 Completed - Heart Surgery Clinical Trials

Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. Using antioxidants during perioperative period may help improve this condition. Vitamin E and zinc have antioxidant effects. In this study, the effects of oral co-administration of zinc and vitamin E supplements on short-term postoperative outcomes in cardiac surgery patients will be investigated.

NCT ID: NCT05162378 Recruiting - Heart Surgery Clinical Trials

Amotosalen and Platelet Transfusion in Adult Heart Surgery

TransAdult
Start date: October 21, 2020
Phase:
Study type: Observational

Blood safety is ensured by the rigorous selection of donors and biological tests. However, infectious agents can escape this detection and be transmitted to recipients during transfusion. Amotosalen is a derivative of psoralens that intercalates with nucleic acids and inactivates them after UV exposure; it therefore makes it possible to inhibit any replication of an infectious agent present. Preliminary studies have shown its safety and efficacy in preventing the transmission of infectious agents during the administration of labile blood products (fresh frozen plasma and platelet concentrates) as well as the absence of loss of efficacy (absence of loss of pro-aggregating and procoagulant properties) of the transfused products. In addition, there is a significant reduction in side effects for platelet concentrates, especially compared to irradiated concentrates. Treatment of platelet concentrates with Amotosalen may be responsible for a reduction in the platelet concentration in each concentrate with an overall decrease in efficiency and transfusion yield compared to untreated concentrates.

NCT ID: NCT04820959 Completed - Heart Surgery Clinical Trials

Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers

CARDIACTIV
Start date: October 4, 2020
Phase: N/A
Study type: Interventional

Heart failure is characterized by cardiac fibrosis linked to extracellular collagen deposits. Collagens are synthesized as soluble precursors, procollagens, which must undergo proteolytic maturation to assemble into fibres. This step is under the control of two extracellular proteins, procollagen C-proteinase enhancer 1 and 2 (PCPE-1 and -2). The mechanism of action of these highly effective and specific activators was recently elucidated by one of our partners. Preliminary results, as well as data from the literature, indicate a strong correlation between the expression rates of PCPEs and cardiac fibrosis. The aim of this study is to validate in humans, by analysis of endomyocardial tissue biopsies, the hypothesis that PCPEs contribute to the anarchic accumulation of collagen during cardiac fibrosis and to evaluate the interest of developing new diagnostic and therapeutic strategies for cardiac fibrosis using PCPE agonists.

NCT ID: NCT04487262 Terminated - Pain, Postoperative Clinical Trials

Timing for Removal of Chest Tubes in Adult Cardiac Surgery

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Rationale: Evidence regarding the timing of chest tube removal after cardiac surgery is sparse. The timing of chest tubes removal constitutes a balancing act between risk of retained blood syndrome, infection, patient discomfort and opioid-related side effects. Several studies have shown that chest tubes can safely be removed on the first postoperative day compared to later. A single retrospective study raised concern as chest tube removal on the day of surgery was associated with an increased requirement of drainage of pleural effusions. Primary Objective: To compare the impact of two standard chest tube removal protocols following open-heart surgery on the incidence of pleural and/or pericardial effusion requiring invasive drainage Secondary Objectives To evaluate the impact of chest tube removal on the day of surgery (DAY0) compared to the first postoperative day (DAY1) regarding: - Comsumption of analgetic drugs - Early postoperative pain - Incidence of infection - Early postoperative respiratory function Study design: Single-center, open, parallel-group, prospective, cluster-randomized controlled trial Alternate assignment of chest tube removal according to Day 0 versus Day 1 protocol based upon the month of surgery (even versus odd months). Study population: 1300 consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.

NCT ID: NCT04338984 Completed - Regional Anesthesia Clinical Trials

Nociception-directed Erector Muscle Spinae Plane Block in Open Heart Surgery

NESP
Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

With the advent of ultrasound (US) guidance, use of regional anaesthesia (RA) is poised to grow and evolve. Recently, cardiac surgery has benefited from newer US guided interfascial techniques as they promise to fulfil all the prerequisites of an enhanced recovery after surgery (ERAS) strategy(1,2). The erector spinae plane (ESP) block represents such an alternative(3). Speed and ease of performance are paramount to encourage spread of its use. Hence, the scope of this trial is to investigate the effects on perioperative opioid consumption and several other secondary outcomes of a minimalist approach encompassing a bilateral single shot ESP block when applied as an adjunct to general anaesthesia.