[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655368":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":50,"studyPopulation":51,"armGroups":46,"interventions":52,"overallOfficials":46,"centralContacts":66,"locations":46,"responsibleParty":76,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":46,"enrollmentInfo":94,"targetDuration":46,"studyType":97,"phases":46,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":108,"whyStopped":46,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":46},{"fullName":5,"class":6},"University of Glasgow","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients for whom meaningful haemodynamic data is obtained at clinically relevant timepoints","Time per patient from initiation of right heart catheter (RHC)-derived continuous cardiac output (CCO) monitoring to planned postoperative RHC removal that high-quality\\* RV\u002Fpulmonary haemodynamic data is obtained: \\*High quality defined as: ≥80% of patients (≥12\u002F15) in whom ≥80% of planned time point measurements can be obtained for the duration of the planned (24 hour) CCO monitoring window. Proportion of planned time per patient in which RHC provides any CCO monitoring for the duration of the planned (24 hour) CCO monitoring window. Number of patients in whom RHC dislodged and\u002For premature removal required.","24 hours",[14,17,20,23,27,30,34,37,40,43],{"measure":15,"description":16,"timeFrame":12},"Haemodynamic 1: PVR vs time","Perioperative PVR (Wood units) vs. time (seconds) area under the curve (AUC)",{"measure":18,"description":19,"timeFrame":12},"Haemodynamic 2: RHC-derived vs. CMR-derived pulmonary artery flow","RHC-derived PA flow (RVP waveform analysis: L\u002Fmin) vs CMR-derived PA flow (L\u002Fmin)",{"measure":21,"description":22,"timeFrame":12},"Vasoreactivity","% reduction in PVR on vasoreactivity testing (before vs during vs after OLV).",{"measure":24,"description":25,"timeFrame":26},"Cardiac biomarker 1: BNP","Serum B-type natriuretic peptide (BNP) level preoperatively, postoperative days 1 and 2.","48 hours",{"measure":28,"description":29,"timeFrame":26},"Cardiac biomarker 2: HsTn","Serum high-sensitivity troponin (HsTn) level preoperatively, postoperative days 1 and 2.",{"measure":31,"description":32,"timeFrame":33},"Clinical indicator 1: Length of stay","Length of postoperative hospital stay (days)","30 days",{"measure":35,"description":36,"timeFrame":33},"Clinical indicator 2: Mortality","Mortality at 30 days.",{"measure":38,"description":39,"timeFrame":33},"Clinical indicator 3: Unplanned hospital readmission (all cause)","Unplanned hospital readmission (all cause) at 30 days.",{"measure":41,"description":42,"timeFrame":26},"Validated patient-reported outcome: quality of recovery","Fifteen-item Quality of Recovery-15 (QoR-15) scale, a fifteen-item patient-reported questionnaire, each question scored on 11-point scale from 0-10, where 0 is very poor and 10 is excellent. Minimum score 0, maximum score 150.",{"measure":44,"description":45,"timeFrame":33},"Postoperative complications at 30 days: highest Clavien-Dindo score","Postoperative in-hospital complications during index surgical admission within 30 days of surgery.\n\nThe outcome measure is the highest Clavien-Dindo score (only score ≥2 included) \\[scored 1-5 with 5 representing the greatest degree of severity\\] informed by the Standardising Endpoints in Perioperative trials consensus definitions. The following complication domains are included:\n\n1. Cardiovascular\n2. Renal\n3. Pulmonary\n4. Infection\n5. Neurological",null,{"allocation":46,"interventionModel":46,"interventionModelDescription":46,"primaryPurpose":46,"observationalModel":48,"timePerspective":49,"maskingInfo":46},"COHORT","PROSPECTIVE","The investigators hypothesise that a transient, acute rise in right ventricular (RV) afterload occurring during lung resection surgery triggers a sterile inflammatory RV injury resulting in persistent RV dysfunction - even in the absence of sustained postoperative pulmonary vascular resistance - which contributes to disabling postoperative dyspnoea and exercise limitation.\n\nTherapeutic pulmonary vasodilation is a mainstay of treatment to reduce RV afterload and improve V\u002FQ matching in complex conditions such as pulmonary hypertension, thoracic organ transplant, respiratory distress syndromes and congenital cardiac disease, with well-established safety and feasibility profiles. Anti-inflammatory and cytoprotective properties have also been demonstrated. The inhaled route provides systemic and renovascular stability, ease of administration, selective targeting of the pulmonary vasculature, with high bioavailability and a short half-life. Unlike traditional approaches focussing on PH management, the application of IPVs for postoperative RV dysfunction may simultaneously address both contractility and afterload reduction.\n\nPerioperative inhaled pulmonary vasodilator (IPV) therapy may prove to protect the RV from the relatively homogenous insult occurring in controlled clinical conditions as described above. Prior to clinical trials of IPVs, it is necessary to first demonstrate the feasibility of continuous RV \u002F pulmonary vascular haemodynamic perioperative monitoring in lung resection, understand the time course of the perioperative afterload insult and characterise pulmonary vasoreactivity. This study seeks to characterise intraoperative haemodynamics, demonstrating feasibility and inform power calculation for a future early phase IPV trial in lung resection patients.\n\nAims\n\nPerform a pragmatic single-centre, prospective study of adults undergoing elective lung resection by VATS and RATS to:\n\n* Assess the feasibility and quality of continuous pressure-derived right ventricular afterload measurement using right heart catheterisation in contemporary elective thoracic surgical patient pathway.\n* Characterise perioperative RV and PA haemodynamics (PVR\u002Ftime area under curve relationship) throughout the perioperative lung resection pathway.\n* Quantify perioperative pulmonary vasoreactivity.\n\nMethods\n\n* RHC and continuous cardiac output (CCO) monitoring with novel \"RVCO\" (right ventricular cardiac output) algorithm to permit continuous perioperative RV\u002Fpulmonary haemodynamic measures.\n* Contrast CMR to quantify cardiopulmonary blood flow, as the gold standard measure against which other measures (RHC) are compared.\n* Interval cardiac biomarker (HsTn \\& BNP) measurement to provide standard for measurement of perioperative RV injury.\n* Characterise perioperative pulmonary vasoreactivity using oxygen and iNO.\n* Conduct validated patient-reported quality of recovery questionnaires.\n\nPrimary objective\n\n• Assess the feasibility of collecting perioperative RHC-derived CCO RV\u002Fpulmonary haemodynamic data in 15 adult patients undergoing elective lung resection.\n\nSecondary objectives\n\n* Obtain perioperative (esp. intraoperative) PVR vs time area under the curve (AUC).\n* Characterise scale, chronology and predictability of intraoperative pulmonary vasoreactivity.\n* Quantify the cardiac bio-inflammatory response to lung resection.\n* Clinical and patient-reported outcome measures.\n* Assess the precision of RHC-measured, RVP waveform-derived PA flow waveform against CMR (gold standard for flow volumes).","The study population will be comprised of elective (planned) adult patients listed for minimally invasive (robotic- or video-assisted thoracoscopic surgery: RATS, VATS) lobectomy for lung cancer under general anaesthesia with one-lung ventilation at GJNH, a large national tertiary cardiothoracic centre located in Clydebank, Glasgow, UK.",[53,57,60,63],{"type":54,"name":55,"description":56,"armGroupLabels":46,"otherNames":46},"DIAGNOSTIC_TEST","Contrast cardiac magnetic resonance imaging","2 scans per participant: 1 pre-operatively and 1 post-operatively.",{"type":54,"name":58,"description":59,"armGroupLabels":46,"otherNames":46},"Right heart catheterisation","Via internal jugular vein using ultrasound and x-ray guidance for diagnostic right heart haemodynamic monitoring",{"type":54,"name":61,"description":62,"armGroupLabels":46,"otherNames":46},"Perioperative plasma sampling","High-sensitivity troponin \\& B-type natriuretic peptide",{"type":6,"name":64,"description":65,"armGroupLabels":46,"otherNames":46},"Quality of recovery scale","Completed by each participants on two occasions: preoperatively and postoperatively. Using validated QoR-15 scale.",[67,73],{"name":68,"role":69,"phone":70,"phoneExt":71,"email":72},"Ben Shelley, MBChB, MD","CONTACT","+44(0)1419515000","4293","benjamin.shelley@glasgow.ac.uk",{"name":74,"role":69,"phone":70,"phoneExt":71,"email":75},"Gareth Lipton, MBChB","gareth.lipton@glasgow.ac.uk",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","Dr Ben Shelley","Honorary Professor",[81],{"name":82,"class":83},"Golden Jubilee National Hospital","OTHER_GOV","100655368","right-ventricular-afterload-indices-in-lung-surgery-100655368",false,"NCT07812207","Right Ventricular Afterload Indices in Lung Surgery","Characterising Pressure-derived Right Ventricular Afterload Indices During Lung Resection Surgery - a Feasibility Study","RAILS","Inclusion Criteria:\n\n* Age ≥18\n* Presumed or confirmed non-small cell lung cancer\n* Planned (elective) minimally invasive (VATS\u002FRATS) lobectomy using OLV\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pulmonary \u002F RV physiological: Severe right sided valvular (tricuspid, pulmonary) disease, Preoperative atrial fibrillation \u002F flutter \u002F non-controlled tachydysrhythmia, Severe RA\u002FRV dilatation, Severe PH (mPAP \\>55mmHg).\n* Awake RHC contraindicated: Severe coagulopathy (PTr \\>1.5, PTTr \\>1.5), Thrombocytopenia (\\\u003C50x109\u002FL), Abnormal vasculature, Unable to lie supine and head down, Endocarditis or intra-cardiac tumour or thrombus, Right-sided valve prosthesis or other implanted cardiac device (e.g. pacing wire), Skin\u002Fsoft tissue infection overlying insertion point.\n* CMR contraindicated: Severe claustrophobia\u002Funable to lie supine, Class III obesity (BMI \\>40), Presence of non-MRI compatible foreign body or implanted device.\n* Gadolinium contrast contraindicated: CMR contraindicated (as above) and\u002For: Intravenous (IV) contrast (Gadolinium) allergy, Acute or chronic renal failure (eGFR \\\u003C59ml\u002Fmin).\n* Surgical \u002F medical: Planned sub-lobar resection \u002F wedge resection \u002F isolated middle lobectomy \u002F segmentectomy \u002F pneumonectomy, Planned secondary procedure (e.g. mediastinal\u002Fcardiac), Pregnancy.\n* Research: Ongoing participation in other investigational research which would undermine the scientific basis of this study.","ALL","18 Years",{"count":95,"type":96},15,"ESTIMATED","OBSERVATIONAL","Lung cancer is a leading cause of cancer death in Scotland and the UK. Surgery, typically using a keyhole approach, provides the best chance of cure. Golden Jubilee National Hospital performs over 600 operations each year, making this the busiest lung surgery department in the country. Unfortunately, some patients suffer disabling breathlessness and a limited ability to perform even very gentle exercise after surgery, even if they had no breathing problems before surgery. Understanding the causes and preventing this breathlessness is the focus of this research.\n\nDespite advances in techniques, lung cancer surgery can result in long-term weakening of the muscular chamber of the right (-hand side of the) heart which pumps blood to the lungs. During surgery, the pressure against which this pump works increases, making it more difficult to push blood into the lungs.\n\nEven after surgery, when the pressure returns to normal, the right heart can remain weak. This weakening can contribute to breathlessness and exercise limitation. Preventing or reducing this right heart weakening may improve quality of life after surgery.\n\nThe investigators are interested in understanding why this weakening occurs after lung surgery and then to develop treatments to prevent it. The answer may lie in reversing the high resistance against which the heart pumps during surgery. Ultimately, the aim is to improve patients' recovery from surgery and improve both breathing and the ability to exercise. This problem may be treatable with existing drugs which are proven to be safe, easy to deliver and are already available. These drugs can be given around the time of surgery.\n\nThis study will not involve administering new treatments, though future clinical trial(s) are anticipated. Participants' care will be the same as is usually provided. Participants taking part will undergo more tests and monitoring than usual to help understand the changes taking place during and after surgery.\n\nBefore a drug trial to test this idea, there are some key things to clarify . This study plans to recruit 15 participants having keyhole lung cancer surgery. The following will be performed:\n\n* Blood Tests: blood samples before and after surgery to check for heart injury.\n* Heart monitoring: temporarily insert a thin tube called a right heart catheter into a large blood vessel in the participants' neck the morning of surgery. This will allow continuous measurement of the pressure in the right heart and lung blood vessels. This will help design and deliver treatments, and how best to measure the effects. This heart catheter will be removed the day after surgery.\n* Heart scans: perform magnetic resonance imaging (MRI) scans before and after surgery to measure blood flow and examine the impact of surgery on the heart.",[100,101,102],"Lung Cancer (Suspected or Confirmed)","Thoracoscopic Lobectomy","One Lung Ventillation (OLV)",[104,105,106,107],"hemodynamics","lung resection","right ventricle","afterload","NOT_YET_RECRUITING","2026-09-03",{"date":111,"type":112},"2026-09-10","ACTUAL",{"date":114,"type":96},"2026-10",{"date":116,"type":96},"2027-10",{"name":5,"class":6}]