[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640072":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":37,"locations":42,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard PEEP Strategy","ACTIVE_COMPARATOR","Patients randomized to this arm will receive a fixed, standard (lower) level of Positive End-Expiratory Pressure (PEEP) throughout the intraoperative period (from intubation to extubation). The specific PEEP value is determined strictly by the surgical stratum: 5 cm H2O for Strata 1 (Non-abdominal surgery), 5 cm H2O for Strata 2 (Major open abdominal surgery), 5 cm H2O for Strata 3 (Major laparoscopic abdominal surgery), and 5 cm H2O for Strata 4 (Low-trauma laparoscopic surgery). All other mechanical ventilation parameters remain standardized (tidal volume 6-8 mL\u002Fkg of ideal body weight).",[13],"Procedure: Intraoperative Positive End-Expiratory Pressure (PEEP) Regulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Higher PEEP Strategy","EXPERIMENTAL","Patients randomized to this arm will receive a fixed, higher level of Positive End-Expiratory Pressure (PEEP) designed for protective lung ventilation throughout the intraoperative period. The specific PEEP value is tailored to the surgical stratum and abdominal risk: 8 cm H2O for Strata 1 (Non-abdominal surgery), 8 cm H2O for Strata 2 (Major open abdominal surgery), 12 cm H2O for Strata 3 (Major laparoscopic abdominal surgery), and 12 cm H2O for Strata 4 (Low-trauma laparoscopic surgery). All other mechanical ventilation parameters remain standardized (tidal volume 6-8 mL\u002Fkg of ideal body weight).",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Intraoperative Positive End-Expiratory Pressure (PEEP) Regulation","Application of fixed PEEP levels calculated according to surgical aggressiveness and the presence of pneumoperitoneum. Standard PEEP arm utilizes PEEP values of 5 cm H2O. Higher PEEP arm utilizes protective PEEP values of 8 or 12 cm H2O. The assigned PEEP strategy is initiated immediately following endotracheal intubation and maintained continuously until extubation.",[15,9],null,[27,31,34],{"name":28,"affiliation":29,"role":30},"Ivan Shcheparev, MD, PhD","Moscow Multi-disciplinary Clinical Center \"Kommunarka\"","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":29,"role":33},"Denis Protsenko, MD, PhD, Professor","STUDY_DIRECTOR",{"name":35,"affiliation":29,"role":36},"Efim Shifman, MD, PhD, Professor","STUDY_CHAIR",[38],{"name":28,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","+7 901 908 90 88","is22@list.ru",[43],{"facility":29,"status":25,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Moscow","108814","Russia","RU",{"type":49,"coordinates":50},"Point",[51,52],37.61781,55.75204,{"lat":52,"lon":51},[55],{"name":28,"role":39,"phone":40,"phoneExt":25,"email":41},{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100640072","optimal-peep-for-postoperative-oxygenation-and-lung-aeration-ultrasvent-2-100640072",false,"NCT07613177","Optimal PEEP for Postoperative Oxygenation and Lung Aeration (ULTRASVENT-2)","Effect of Positive End-Expiratory Pressure (PEEP) Level on Postoperative Oxygenation and Lung Aeration Assessed by Lung Ultrasound Monitoring: A Multicenter Randomized Controlled Trial (ULTRASVENT-2)","ULTRASVENT-2","Inclusion Criteria:\n\n* Age greater than or equal to 18 years.\n* Planned elective non-cardiac and non-thoracic surgical intervention requiring general anesthesia with mechanical ventilation.\n* Airway protection utilizing an endotracheal tube.\n* Assignment to one of the four specific surgical strata: non-abdominal, major open abdominal, major laparoscopic abdominal, or low-trauma laparoscopic surgery.\n* Baseline lung ultrasound showing no pathological findings, corresponding to a total preoperative LUS score of 0.\n* Technical feasibility of performing a postoperative lung ultrasound within the first 2 hours after the completion of surgery.\n* Signed written informed consent to participate in the clinical trial.\n\nExclusion Criteria:\n\n* Planned cardiac or thoracic surgery (e.g., coronary artery bypass grafting, valve replacement, heart transplantation, lung resection, esophageal surgery).\n* Pneumothorax diagnosed before or during the surgical procedure.\n* Inability to adequately visualize the target dorsal-basal lung zones by ultrasound due to physical limitations (e.g., morbid obesity, massive surgical dressings, anatomical anomalies, or dermatological lesions in the scanning area).\n* Presence of hydrothorax detected on the baseline preoperative ultrasound.\n* Confirmed perioperative aspiration of gastric contents or other foreign material.\n* Any pathological changes identified during the baseline ultrasound of the dorsal-basal lung regions (a total preoperative LUS score greater than 0).\n* Requirement for massive blood transfusion during the surgery, defined according to local institutional criteria.\n* Surgical interventions directly involving or violating the diaphragm.\n* Expected inability to conduct reliable postoperative clinical and ultrasound assessments (e.g., need for deep sedation preventing wakefulness and contact, or planned transfer to another facility).","ALL","18 Years",{"count":69,"type":70},360,"ESTIMATED","INTERVENTIONAL",[73],"NA","The purpose of this multicenter, randomized controlled trial (ULTRASVENT-2) is to evaluate the effect of different positive end-expiratory pressure (PEEP) levels on postoperative oxygenation and lung aeration in adult patients undergoing elective non-cardiac and non-thoracic surgery under general anesthesia. Moving away from traditional binary outcomes, this study utilizes a continuous functional metric, the non-invasive oxygenation index SpO2\u002FFiO2 (S\u002FF ratio), as the primary endpoint to precisely capture the degree of respiratory function preservation.\n\nPatients will be stratified into four distinct surgical cohorts based on the type and aggressiveness of the procedure: non-abdominal surgery, major open abdominal surgery, major laparoscopic abdominal surgery, and low-trauma laparoscopic surgery. This adaptive design aims to investigate how protective PEEP strategies interact with varying degrees of surgical trauma and intraoperative pneumoperitoneum, allowing the optimization of mechanical ventilation parameters for routine clinical practice.",[76,77,78,79,80],"Postoperative Complications","Respiratory Insufficiency","Pulmonary Atelectasis","Positive-End Expiratory Pressure","Hypoxemia",[82,83,84,85,86],"Lung ultrasound","S\u002FF ratio","Perioperative lung protection","Laparoscopic surgery","Open laparotomy","NOT_YET_RECRUITING","2026-05-23",{"date":90,"type":91},"2026-05-29","ACTUAL",{"date":93,"type":70},"2026-07-01",{"date":95,"type":70},"2026-12-20",{"name":5,"class":6},1]