[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607313":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":40,"locations":46,"responsibleParty":63,"collaborators":31,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":31,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":31,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":93,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University General Hospital of Patras","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Lung Protective Ventilation","CONVENTIONAL LUNG PROTECTIVE VENTILATION\n\nThis group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP 8 cm H20 Tidal Volume (VT) 8 ml\u002Fkg Ideal Body Weight (IBW) Respiratory Rate (RR) --\\> Arterial Partial CO2 Pressure (PaCO2) = 35-45 mmHg Inspired Oxygen Fracture (FiO2) 0.4 - 0.5 --\\> Peripheral Oxygen Saturation (SpO2) \\> 93% Recruitment Maneuver (as described) every hour",[12],"Procedure: Lung Protective Ventilation",{"label":14,"type":15,"description":16,"interventionNames":17},"Minimum Driving Pressure","ACTIVE_COMPARATOR","This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP; Initially 8 cm H2. Titrated at level with Minimum Driving Pressure after first recruitment - titration maneuver followed by new recruitment maneuver VT 8 ml\u002Fkg IBW RR --\\> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --\\> SpO2 \\> 93% Recruitment Maneuver (as described) every hour",[18],"Procedure: PEEP titration for Minimum Driving Pressure",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","PEEP titration for Minimum Driving Pressure","This group is mechanically ventilated with Invasive Mechanical Ventilation with Volume Control Ventilation mode with PEEP Initially 8 cm H2O. Afterwards, the lungs are recruited with the aforementioned maneuver. During subsequent derecruitment, PEEP is decreased by 2 cm H20 and compliance is noted in each stage. The goal is to find PEEP with maximum compliance (Cmax). A new recruitment maneuver follows and during derecruitment PEEP is set at the optimum value that was previously defined.\n\nVT 8 ml\u002Fkg IBW RR --\\> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --\\> SpO2 \\> 93% Recruitment Maneuver (as described) every hour",[14],[26,27],"Maximum compliance mechanical ventilation","Cmax Mechanical Ventilation",{"type":21,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"This group is mechanically ventilated with Invasive Mechanical Ventilation with Volume Control Ventilation mode with PEEP 8 cm H2O. VT 8 ml\u002Fkg IBW RR --\\> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --\\> SpO2 \\> 93% Recruitment Maneuvers (as described) every hour",[9],null,[33,37],{"name":34,"affiliation":35,"role":36},"Diamanto Aretha, A. Professor","University of Patras","STUDY_DIRECTOR",{"name":38,"affiliation":35,"role":39},"Antonios Kostouros, Resident","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Antonios D Kostouros, Resident","CONTACT","+306975920528","kostouros.a@yahoo.com",[47],{"facility":48,"status":49,"city":50,"state":31,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University Hospital of Patras","RECRUITING","Pátrai","26504","Greece","GR",{"type":55,"coordinates":56},"Point",[57,58],21.73508,38.2462,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":31,"phoneExt":31,"email":31},"Diamanto Aretha, Associate Professor",{"type":39,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Antonios Kostouros","Prinsipal Investigator, Antonios Kostouros","100607313","driving-pressure-during-surgeries-with-high-risk-for-postoperative-pulmonary-complications-100607313",false,"NCT07186933","Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications","Inclusion Criteria\n\n* \\>17 years old\n* Surgery with general anesthesia \\& invasive mechanical ventilation\n* Preoperative ARISCAT score estimation \\>25\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* Preoperative ARISCAT score estimation \\\u003C26\n* Women during pregnancy or just given birth\n* Other type of anesthesia (Not general)\n* Contraindication of administration of neuromuscular blockade agents.\n* Contraindication of cease of spontaneous ventilation.\n* Mechanical ventilation without endotracheal intubation.\n* Severe heart failure \u002F Severe cardiac arrhythmia.\n* Severe emphysematous lung disease.\n* Patient denial of participation in the trial.",true,"ALL","18 Years",{"count":76,"type":77},200,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial is to compare two different types of perioperative mechanical ventilation (MV), specifically Protective Mechanical Ventilation (PMV) and MV with the lowest possible Driving Pressure (ΔP), in relation to the appearance of postoperative pulmonary complications (PPCs) in adult patients who are operated and have higher risk of PPCs.\n\nThe main questions it aims to answer are:\n\n* Is MV with lower ΔP better than conventional PMV in preventing PPCs in patients with higher risk for PPCs?\n* Does MV with lower ΔP decrease hospital stay, Intensive Care Unit (ICU) need and mortality?\n* Does MV with lower ΔP suit better than PMV to lung characteristics and needs intraoperatively?\n\nResearchers will compare MV with the lowest possible Driving Pressure (ΔP) to Protective Mechanical Ventilation (PMV) to see if any of this is more protective than the other concerning PPCs.\n\nAll participants will receive perioperative MV.\n\nHalf of them will receive conventional Protective Mechanical Ventilation (PMV). This will include well known generally protective settings for mechanical ventilation of patients, concerning volumes, pressures, respiratory rate, inspiratory gases and ventilation maneuvers.\n\nThe rest of participants will be ventilated with the lowest possible Driving Pressure (ΔP). This will be similar to PMV in the chosen volumes, respiratory rate, inspiratory gases and ventilation maneuvers. However, the pressure inside lung at the end of expiration, eg Positive End Expiratory Pressure (PEEP), will be not be preset for every patient. Initially, the investigators will perform a maneuver that will quantify each individual's lung characteristics and mechanics. According to this, the investigators will find the exact PEEP that seems to suit each patients lungs most, and use this perioperatively, trying to provide lungs the best conditions every time.\n\nAfter the completion of the operation, all the patients will be screened for PPCs, via arterial blood testing and chest X ray, and the results will be statistically analyzed trying to find if any of the forementioned strategies of mechanical ventilation surpasses the other concerning PPCs appearance. PPCs include atelectasis, respiratory failure, bronchospasm, pleural effusion, pneumonia, aspiration and pneumothorax.\n\nFurthermore hospital stay, ICU need and mortality will be noted. Finally, measurements of perioperative lung pressures, volumes and derived variables will be noted and compared statistically as well.",[83,84,85,86,87,88,89,90,91,92],"Postoperative Pulmonary Atelectasis","Postoperative Pulmonary Complications","Postoperative Respiratory Failure","Postoperative Bronchospasm","Postoperative Pleural Effusion","Postoperative Pneumothorax","Postoperative Pneumonia","Postoperative Aspiration Pneumonitis","Mechanical Power","Driving Pressure",[92,91,94,95,84,85,96],"Atelectasis","Pulmonary Complications","Elastic Power","2026-02-08",{"date":99,"type":100},"2026-02-11","ACTUAL",{"date":102,"type":100},"2025-11-03",{"date":104,"type":77},"2027-11-30",{"name":5,"class":6},1]