[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643157":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":86,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Cantonal Hospital of St. Gallen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Flow-Controlled Ventilation","EXPERIMENTAL","The intervention to be investigated is an intraoperative ventilation strategy with individualized FCV with dynamic compliance guided titration of PEEP and driving pressure during all phases of intraoperative ventilation, and in particular OLV, aiming at maximum recruitment of lung tissue without causing overdistention.",[13],"Procedure: Flow-Controlled Ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Volume-Controlled Ventilation","ACTIVE_COMPARATOR","intraoperative ventilation strategy with current best practice lung protective VCV with standard PEEP",[19],"Procedure: Volume-Controlled Ventilation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","In the FCV group, patients will be ventilated using the EVONE ventilator with dynamic compliance-guided titration of PEEP and driving pressure. Ventilation starts with a PEEP of 5 cmH2O and a Ppeak of 15 cmH2O. Both parameters are increased stepwise to identify the PEEP associated with the highest tidal volume and best dynamic compliance, followed by further adjustment of Ppeak to determine the optimal driving pressure. No recruitment maneuvers are routinely performed. Ventilation is provided with an I:E ratio of 1:1, while flow is adjusted to maintain normocapnia (target etCO2 4.5-5.8 kPa). FiO2 is titrated to maintain SpO2 \\>92%. Rescue crossover to conventional VCV is permitted in cases of ventilator malfunction or unresolved impairment of oxygenation, ventilation, or CO2 elimination, at the discretion of the attending anesthesiologist.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"In the VCV group, intraoperative ventilation will be provided using standard anesthesia ventilators routinely used at the participating centers. Patients will receive lung-protective VCV with tidal volumes of 7-9 ml\u002Fkg predicted body weight during two-lung ventilation and 5-6 ml\u002Fkg during one-lung ventilation. Respiratory rate and FiO2 will be adjusted to maintain normocapnia (target etCO2 4.5-5.8 kPa) and SpO2 \\>92%, with an inspiratory-to-expiratory ratio of 1:1 to 1:2. Ventilation will start with a PEEP of 5 cmH2O, while further adjustments of ventilatory parameters, including PEEP, are left to the discretion of the attending anesthesiologist according to routine clinical practice. Rescue crossover to FCV is not permitted; however, switching to another conventional ventilation mode is allowed in cases of ventilator malfunction or unresolved impairment of oxygenation, ventilation, or CO2 elimination.",[15],[30],{"name":31,"affiliation":32,"role":33},"Timur Yurttas, MD","Department of Anaesthesiology, HOCH Health Ostschweiz, Cantonal Hospital St. Gallen","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","0041714949158","info@proflow-series.org",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Sara Wijnant, MD, PhD","0041714941501","sara.wijnant@ugent.be",[44],{"facility":32,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Sankt Gallen","Canton of St. Gallen","9007","Switzerland","CH",{"type":51,"coordinates":52},"Point",[53,54],9.37477,47.42391,{"lat":54,"lon":53},[57],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":58},"timur.yurttas@h-och.ch",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Timur Yurttas","Principal Investigator, Senior Physician, MD, Department of Anaestheisology","100643157","flow-controlled-ventilation-to-improve-postoperative-pulmonary-outcome-after-thoracic-surgery-100643157",false,"NCT07623395","Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery","PROtective Ventilation With FLOW-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After THORACic Surgery - an International Multicenter Pilot Randomized Clinical Trial","PROFLOW-THORAC","Inclusion Criteria:\n\n* aged ≥ 18 years; and\n* scheduled for elective open, video- or robot-assisted thoracic surgery with one-lung ventilation using a double-lumen tube (DLT); and\n* able to give written informed consent.\n\nExclusion Criteria:\n\n* body weight \\\u003C 40 kg;\n* ASA score IV - VI;\n* lung separation with other method than DLT (e.g. difficult airway, tracheostomy);\n* previous lung surgery;\n* COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax;\n* uncontrolled asthma;\n* Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4;\n* documented pulmonary arterial hypertension \\>25 mmHg mPAP at rest or \\>40mmHg syst. (estimated by ultrasound) or \\>20 mmHg mPAP measured by right heart catheterization, or pulmonary vascular resistance \\> 2.0 Wood units;\n* documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others);\n* planned mechanical ventilation after surgery;\n* bilateral procedures;\n* surgery in prone position;\n* persistent hemodynamic instability, intractable shock;\n* intracranial injury or tumor;\n* esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation;\n* presence before induction of anesthesia of one of the adverse events, listed as postoperative pulmonary complications (aspiration, moderate respiratory failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary oedema, pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung hemorrhage);\n* documented preoperative hypercapnia \\> 45mmHg (6kPa)\n* previous enrolment in the current study;\n* being the study investigator of this study, his\u002Fher family members, employees and other dependent persons;\n* if female and of childbearing potential, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; or\n* no written informed consent.","ALL","18 Years",{"count":73,"type":74},140,"ESTIMATED","INTERVENTIONAL",[77],"NA","In an international multicenter randomized clinical pilot trial, intraoperative flow-controlled ventilation (FCV) will be compared with volume-controlled ventilation (VCV) in patients scheduled for (open, video- or robot-assisted) thoracic surgery with one-lung ventilation (OLV). This pilot trial is designed to test the feasibility and safety of FCV during all phases of intraoperative ventilation, and in particular during OLV, and to inform the design of a future trial testing the efficacy of FCV with regard to postoperative outcomes, including postoperative pulmonary complications (PPC).\n\nThe ventilation modes are conducted with CE-marked medical devices (anesthesia ventilators or medical ventilators), however these medical devices themselves are not under investigation. All CE-marked standard medical devices from varied manufacturers in use at the participating study centers will be used in full accordance with their instructions for use. FCV has shown safety and feasibility in various surgical settings, including thoracic surgery with OLV, however its feasibility in a multicenter trial has not been investigated yet.",[80,81],"Mechanical Ventilation","Postoperative Pulmonary Complications (PPCs)",[9,83,84,85],"Thoracic Surgery","One-Lung Ventilation","Mechanical Power","NOT_YET_RECRUITING","2026-06-28",{"date":89,"type":90},"2026-07-01","ACTUAL",{"date":92,"type":74},"2026-09-01",{"date":94,"type":74},"2027-12-01",{"name":5,"class":6},1]