[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemodynamic-changes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemodynamic-changes":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,79,116,141,166,186,214,242,266],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100639949","right-ventricular-function-and-respiratory-acidosis-after-cardiac-surgery-100639949",false,"NCT07619274","Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery","Inclusion Criteria:\n\n* Previously included and complete study NCT05886413 or NCT06826794\n\nExclusion Criteria:\n\n* Absence of one or more of the following hemodynamic measurements: systolic or diastolic pulmonary artery pressure, central venous pressure, cardiac output\n* Absence of arterial blood gas on arrival to the intensive care unit","ALL","18 Years",{"count":18,"type":19},220,"ESTIMATED","OBSERVATIONAL","Right heart dysfunction remains a frequent cause of morbidity and mortality after cardiac surgery. Respiratory acidosis, particularly when accompanied by hypoxemia, plays a significant role in right heart failure, primarily by increasing right ventricular afterload through pulmonary vasoconstriction and elevated pulmonary arterial pressures. This phenomenon leads to increased right ventricular workload, causing dilation, decreased contractility, and ultimately right heart failure. The study aims to evaluate the effect of respiratory acidosis on right ventricular function after cardiac surgery.",[23,24,25,26],"Respiratory Acidosis in ICU Patients","Right Ventricular (RV) Dysfunction","Hemodynamic Changes","Mechanical Ventilation","NOT_YET_RECRUITING","2026-05-28",{"date":30,"type":31},"2026-06-01","ACTUAL",{"date":33,"type":19},"2026-05",{"date":35,"type":19},"2026-10",{"name":37,"class":38},"Laval University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":16,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":55,"conditions":56,"keywords":65,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":39},"100630322","phase-1-influence-of-lung-volume-optimization-maneuver-on-cardiac-output-and-lung-compliance-in-ventilated-children-with-congenital-heart-disease-undergoing-surgical-repair-100630322","NCT07486167","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease","ILOCO-CHD","Inclusion Criteria:\n\n* Inclusion Criteria\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.","0 Days",{"count":50,"type":19},80,"INTERVENTIONAL",[53,54],"PHASE1","PHASE2","The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.\n\nThe primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.\n\nSecondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.",[57,58,26,59,60,61,62,63,25,64],"Congenital Heart Disease","Cardiopulmonary Bypass","Peep Titration in Lung Protective Ventilation","Positive End-expiratory Pressure (PEEP)","Lung Volume","Lung Mechanics","Children","Cardiac Surgery",[66,67,68,69],"cardiopulmonary interactions","end-expiratory lung volume","electrical impedance tomography","PEEP titration","2026-04-26",{"date":72,"type":31},"2026-04-30",{"date":74,"type":19},"2026-09-01",{"date":76,"type":19},"2028-12-31",{"name":78,"class":38},"Charite University, Berlin, Germany",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":51,"phases":88,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":39},"100635703","dexmedetomidine-and-propofol-for-sedation-in-cataract-surgery-100635703","NCT07556133","Dexmedetomidine and Propofol for Sedation in Cataract Surgery.","Dexmedetomidine vs Propofol for Sedation in Cataract Surgery : a Prospective Randomized Controlled Trial.","Inclusion Criteria:\n\n* Adults undergoing cataract surgery\n\nExclusion Criteria:\n\n* Severe hepatic insufficiency\n* Third degree AV block\n* Patient refusal",{"count":87,"type":19},1000,[89],"NA","The goal of this prospective, randomized, single-blinded is to learn if there is an ideal sedation protocol in cataract surgery in adults.\n\nThe main questions it aims to answer are:\n\n* Does the combination of Dexmedetomidine and Propofol affect significantly Ramsay sedation scale, compared to Dexmedetomidine and compared to Propofol?\n* How does each sedation protocol affect hemodynamics? (Heart rate and blood pressure)\n* Are respiratory events more common in a certain group?\n* Is the surgeon's satisfaction similar among groups?\n* Are adverse effects (bradycardia, hypotension, nausea) more common in a certain group?\n\nResearchers will compare 3 sedation protocols : Dexmedetomidine versus Propofol versus the combination of these 2 drugs and to see if one protocol is overall superior to the others. Fentanyl will also be used in all 3 sedation protocols.\n\nParticipants will :\n\n* Receive one of these three protocols\n* Be operated for one or both eyes\n* Monitored during the whole surgery and in the recovery room\n* Be evaluated by the Ramsay sedation scale by a trained Anesthesiologist or CRNA during surgery and in the recovery room Surgeons will be asked about how much they were satisfied.",[92,93,94,25,95,96,97,98,99,100],"Sedation","Cataract","Hemodynamic","Dexmedetomidine","Propofol Dosage","Fentanyl","Bradycardia","Tachycardia","Nausea and Vomiting",[102,93,103,104,105],"Dexmedetomidine and propofol in cataract surgery","sedation","Dexmedetomidine in cataract surgery","Sedation for cataract surgery","RECRUITING","2026-04-21",{"date":109,"type":31},"2026-04-29",{"date":111,"type":31},"2025-11-09",{"date":113,"type":19},"2026-12-09",{"name":115,"class":38},"Saint-Joseph University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100635167","ivc-collapsibility-index-in-lumbar-stabilization-surgery-100635167","NCT07549165","IVC Collapsibility Index in Lumbar Stabilization Surgery","Hemodynamic Assessment Using the Inferior Vena Cava Collapsibility Index in Patients Undergoing Lumbar Stabilization Surgery","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients classified as ASA physical status I-II-III\n* Patients scheduled for elective lumbar spine stabilization surgery under general anesthesia\n* Ability to obtain adequate inferior vena cava (IVC) ultrasonographic imaging\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n\n  * Emergency surgery\n  * American Society of Anesthesiologists (ASA) physical status IV\n  * Patients undergoing revision lumbar stabilization surgery\n  * Baseline systolic blood pressure \\>180 mmHg or \\\u003C90 mmHg\n  * Heart failure with ejection fraction (EF) \\\u003C40%\n  * Pulmonary artery pressure (PAP) \\>40 mmHg\n  * Presence of intra-abdominal mass, ascites, or increased intra-abdominal pressure\n  * Body mass index (BMI) \\>30 kg\u002Fm²\n  * Pregnancy\n  * Patients with neurological or psychiatric disorders\n  * Inability to obtain adequate inferior vena cava (IVC) ultrasonographic imaging\n  * Refusal to provide written informed consent",{"count":124,"type":19},128,"This study aims to evaluate perioperative hemodynamic changes using the inferior vena cava (IVC) collapsibility index in patients undergoing lumbar stabilization surgery under general anesthesia. The IVC diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points. Hemodynamic parameters such as blood pressure and heart rate will also be recorded. The study seeks to determine whether the IVC collapsibility index can be used as a non-invasive indicator of intravascular volume status and hemodynamic changes during lumbar spine surgery.",[127,25,128],"Lumbar Spine Surgery","Intravascular Volume Status",[130],"Inferior Vena Cava • IVC Collapsibility Index • Lumbar Stabilization Surgery • Hemodynamic Monitoring","2026-04-17",{"date":133,"type":31},"2026-04-23",{"date":135,"type":31},"2026-02-15",{"date":137,"type":19},"2026-07-15",{"name":139,"class":38},"Trabzon Kanuni Education and Research Hospital",2,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":15,"minAge":149,"maxAge":16,"enrollmentInfo":150,"targetDuration":4,"studyType":51,"phases":151,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":39},"100607835","phase-1-influence-of-personalized-lung-volume-optimization-maneuver-on-lung-function-and-cardiac-performance-in-children-100607835","NCT07193719","Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children","Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children","ILOCO","CHD study:\n\nInclusion Criteria\n\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.\n\nECMO study Inclusion Criteria\n\n* patients with respiratory failure on ECMO or at risk for ECMO\n* invasive ventilation\n\nExclusion Criteria:\n\n\\- severe lung hypoplasia or interstitial lung disease","0 Years",{"count":50,"type":19},[53,54],"The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in\n\n1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and\n2. study) in children with severe respiratory failure at risk for or need for ECMO.\n\nThe main questions it aims to answer are:\n\nMain hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:\n\n* cardiac performance\n* lung function\n\nDoes it make a difference in:\n\n* length of ventilation\n* ventilation\u002Fperfusion mismatch of the lung\n* need for vasopressor support?\n\nMain hypotheses of ECMO study:\n\nDoes a LVOM in children\u002Finfants with severe respiratory failure \u002FARDS\n\n* improve lung compliance and gas exchange\n* facilitate lung protective ventilation according to PALICC-2 guidelines\n* improve lung aeration and V\u002FQ-matching assessed with EIT\n\nDoes it make a difference in\n\n* need for ECMO\n* duration of ECMO runs\n* hemodynamics stability",[57,58,64,26,60,61,62,25,63,154,155],"ARDS","ECMO",[66,67,69,154,155,157],"cardiopulmonary bypass","2026-04-05",{"date":160,"type":31},"2026-04-09",{"date":162,"type":31},"2025-12-05",{"date":164,"type":19},"2027-12-20",{"name":78,"class":38},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":39},"100631339","assessment-of-venous-return-during-volume-expansion-a-prospective-observational-study-100631339","NCT07499388","Assessment of Venous Return During Volume Expansion: a Prospective Observational Study","PSM-PVC-RITVEN","Inclusion Criteria:\n\n* Critically ill patients admitted to the intensive care unit\n* Invasive or minimally invasive hemodynamic monitoring\n* Clinical indication for volume expansion with 500 mL of crystalloids\n\nExclusion Criteria:\n\n* Suspected or confirmed pregnancy\n* Clinical conditions that may reduce the reliability of hemodynamic monitoring:\n* Severe aortic stenosis or regurgitation\n* Severe mitral stenosis or regurgitation\n* History of peripheral arterial disease\n* Clinical contraindications to the supine position",{"count":174,"type":19},45,"According to Guyton's model of venous return, the fluids that effectively increase cardiac output are those that, once administered, increase the vascular stressed volume, thereby increasing the mean systemic filling pressure (Pms) without increasing the central venous pressure (CVP). In this way, since the gradient between Pms and CVP increases, venous return-and consequently cardiac output-also increases.\n\nIn cases where physiologically ineffective fluids are administered, the situation arises in which, in addition to increasing the stressed volume and thus Pms, CVP also increases. As a result, the gradient between Pms and CVP remains unchanged, and cardiac output does not increase.\n\nThe hypothesis is that only a portion of the fluids administered during volume expansion are actually effective in increasing the gradient between Pms and CVP.",[25],"2026-03-23",{"date":179,"type":31},"2026-03-30",{"date":181,"type":31},"2025-03-01",{"date":183,"type":19},"2026-07",{"name":185,"class":38},"Università Politecnica delle Marche",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":15,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":51,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":39},"100626415","phase-4-effect-of-nalbuphine-versus-fentanyl-on-hemdoynamic-effects-of-laryngoscopy-100626415","NCT07435337","Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy","COMPARISON OF HEMODYNAMIC EFFECTS OF NALBUPHINE VERSUS FENTANYL: A RANDOMIZED, DOUBLE-BLINDED INTERVENTIONAL STUDY IN PATIENTS ON CARDIOPULMONARY BYPASS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI","Inclusion Criteria:\n\n* Weighing 40-70kg\n\n  * ASA III of either sex\n  * Undergoing cardiac surgery with CPB\n\nExclusion Criteria:\n\n• History of Drug Allergy • Pre-existing Asthma • Renal or Hepatic dysfunction • Extreme obesity • Pregnant \u002F lactating patients • Difficult intubation\u002Fprolonged intubation",true,"40 Years","60 Years",{"count":197,"type":19},98,[199],"PHASE4","Participants will undergo routine pre-operative evaluation. An intravenous line will be placed in the recovery area. On arrival in the operating room, standard monitoring (blood pressure, heart rate, oxygen saturation, ECG, breathing monitor, and temperature) will be applied. A central venous catheter and an arterial line will be inserted under local anesthesia using sterile technique.\n\nBefore anesthesia induction, patients will receive premedication including midazolam and an opioid pain-relief injection given slowly through the vein. General anesthesia will then be induced with etomidate. After adequate sedation, a muscle relaxant (atracurium) will be administered, and the patient will be ventilated with 100% oxygen using a face mask. The breathing tube will then be inserted and correct placement confirmed.\n\nDuring surgery, anesthesia will be maintained with oxygen, sevoflurane gas, and a continuous atracurium infusion. Hemodynamic parameters such as heart rate and blood pressure will be monitored throughout the peri-intubation and intraoperative period.",[202,25],"Laryngoscopy",[204],"Laryngoscopic stress response","2026-02-20",{"date":207,"type":31},"2026-02-27",{"date":209,"type":31},"2026-02-21",{"date":211,"type":19},"2026-05-21",{"name":213,"class":38},"Rawalpindi Institute of Cardiology",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":51,"phases":223,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100621913","effect-of-patient-position-on-bupivacaine-dose-requirement-and-hemodynamic-stability-in-spinal-anesthesia-100621913","NCT07376798","Effect of Patient Position on Bupivacaine Dose Requirement and Hemodynamic Stability in Spinal Anesthesia","Inclusion Criteria:\n\n* Age 18-70 years\n* American Society of Anesthesiologists (ASA) physical status classification I-II\n* Scheduled for elective urogenital surgery\n* Suitable candidate for spinal anesthesia\n* Able to read, understand, and provide written informed consent\n* Body Mass Index (BMI) less than 35 kg\u002Fm²\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* Contraindications to spinal anesthesia (coagulopathy, infection at injection site, patient refusal)\n* History of neurological disease\n* Spinal deformity or previous spinal surgery\n* History of allergic reaction to local anesthetics (amide-type)\n* ASA physical status classification III or higher\n* Emergency surgery\n* Pregnancy\n* Psychiatric illness preventing effective communication\n* Refusal to participate in the study\n* Unable to understand or provide informed consent","70 Years",{"count":222,"type":19},100,[89],"This study compares different combinations of local anesthetic doses and patient positions during spinal anesthesia for urogenital surgery. Spinal anesthesia is a common and safe technique where medication is injected into the lower back to numb the body during surgery.\n\nThe study will test two different doses of bupivacaine (a numbing medication): a lower dose (8 mg) and a standard dose (12 mg). It will also test two different patient positions after the spinal injection: lying flat (neutral position) and lying with the head slightly lower than the feet (Trendelenburg position).\n\nParticipants will be randomly assigned to one of four groups:\n\n* Group 1: Lower dose + lying flat\n* Group 2: Lower dose + head-down position\n* Group 3: Standard dose + lying flat\n* Group 4: Standard dose + head-down position\n\nThe study will measure how well the anesthesia works, how high the numbness spreads in the body, and how it affects blood pressure and heart rate. The goal is to find the best combination of dose and position that provides good anesthesia while keeping blood pressure stable.\n\nThis research may help doctors choose the safest and most effective anesthesia approach for each patient based on their individual needs.",[226,25,227,228],"Spinal Anesthesia","Patient Positions","Bupivacaine",[226,228,230,231],"Patient Positioning","hemodynamic changes","2026-01-21",{"date":234,"type":31},"2026-01-29",{"date":236,"type":19},"2026-01-30",{"date":238,"type":19},"2026-06-30",{"name":240,"class":241},"University of Health Sciences Balikesir Hospital Eduation and Research","OTHER_GOV",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":51,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":39},"100612260","effect-of-stress-ball-during-chest-tube-removal-after-open-heart-surgery-100612260","NCT07251270","Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery","Effect of Stress Ball on Pain, Anxiety Levels, and Hemodynamic Variables During Chest Tube Removal After Open Heart Surgery","Stress ball","Inclusion Criteria:Patients will be included : have only one chest tube after open heart surgery,\n\n* are 18 years of age or older,\n* are conscious and cooperative,\n* speak and understand Turkish,\n* have a stable general condition and hemodynamic variables,\n* have a planned surgical procedure,\n* have no previous chest tube experience,\n* have no psychiatric diagnosis,\n* are not using psychiatric and\u002For local neuromuscular blocking medications,\n* agree to participate in the study (sign the Informed Consent Form).\n\nExclusion Criteria:Patients who do not have a chest tube or have multiple chest tubes after open heart surgery,\n\n* Are under 18 years of age,\n* Are conscious and uncooperative,\n* Do not speak or understand Turkish,\n* Are in an unstable general condition or hemodynamic variables,\n* Have undergone emergency surgery,\n* Have previous chest tube placement experience,\n* Have a current psychiatric diagnosis,\n* Are taking psychiatric and\u002For local neuromuscular blocking medications,\n* Do not agree to participate in the study (do not sign the Informed Consent Form) will not be included in the study.",{"count":251,"type":19},46,[89],"15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group.\n\nThe chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.",[255,25,256],"Pain","Anxiety","2025-12-01",{"date":259,"type":31},"2025-12-08",{"date":261,"type":31},"2025-11-27",{"date":263,"type":19},"2026-06-20",{"name":265,"class":38},"Mersin University",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":51,"phases":276,"briefSummary":277,"conditions":278,"keywords":282,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":39},"100594234","cerebral-regional-oxygen-saturation-during-tavi---the-cros-tavi-prospective-registry-100594234","NCT07016789","Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry","Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves","CROS-TAVI","Inclusion Criteria:\n\nSigned informed consent prior to any study-specific procedures\n\nDiagnosis of severe degenerative aortic valve stenosis with echocardiographic criteria:\n\nMean gradient \\> 40 mm Hg, or\n\nJet velocity \\> 4.0 m\u002Fs, or\n\nAortic valve area (AVA) \\\u003C 0.8 cm² (or AVA index \\\u003C 0.5 cm²\u002Fm²)\n\nSymptomatic aortic stenosis defined as NYHA functional class ≥ II\n\nExclusion Criteria:\n\nSymptomatic carotid artery disease or indication for carotid revascularization\n\nCardiogenic shock or inotropic support required prior to the procedure\n\nActive neurodegenerative disease\n\nContraindications as determined by anesthesiology screening\n\nAge \\\u003C 18 years\n\nContraindications to NIRS monitoring\n\nST-elevation myocardial infarction or cardiogenic shock within 48h before enrollment\n\nEmergency TAVI due to decompensated AV stenosis\n\nMalignancy or comorbidities with life expectancy \\\u003C 12 months\n\nInability to comply with the study protocol\n\nStroke or transient ischemic attack within 6 months\n\nRenal insufficiency (creatinine \\> 3.0 mg\u002FdL) or dialysis dependency\n\nSevere left ventricular dysfunction (LVEF \\\u003C 30%)\n\nSignificant mixed valvular disease (e.g., severe mitral or tricuspid regurgitation)\n\nIntracardiac mass, thrombus, or vegetation\n\nChronic corticosteroid use\n\nParticipation in another investigational drug or device study\n\nActive bacterial endocarditis or other active infections",{"count":275,"type":19},40,[89],"This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation). The study uses a non-invasive monitoring system (NIRS) to track brain oxygenation (rSO₂) in real time.\n\nThe goal is to understand whether balloon-expandable, intra-annular self-expanding, or supra-annular self-expanding valves lead to different levels or patterns of cerebral oxygenation. This may help identify early warning signs for delayed hemodynamic recovery, stroke, or delirium.\n\nParticipants will be randomly assigned to receive one of:\n\nA balloon-expandable valve (Group A), or\n\nA self-expanding valve (Group B), with further randomization into:\n\nGroup B1: intra-annular valve (NAVITOR)\n\nGroup B2: supra-annular valve (EVOLUT)\n\nThe procedure, follow-up, and data collection will follow standard clinical practice. No experimental devices or drugs are used. Patients will not undergo any additional risk or burden beyond what is normally expected during TAVI.\n\nThe study is being conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and aims to enroll 40 patients. No compensation is provided, and participation is voluntary.",[279,280,281,25],"Aortic Stenosis Disease","TAVI(Transcatheter Aortic Valve Implantation)","Cerebral Oxygen Saturation",[283,284,281,285,286,287],"TAVI","Aortic Valve Stenosis","NIRS","Balloon-Expandable Valve","Self-Expanding Valve","2025-06-23",{"date":290,"type":31},"2025-06-26",{"date":292,"type":19},"2025-06",{"date":294,"type":19},"2026-06",{"name":296,"class":38},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]