[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652517":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The University of Texas Medical Branch, Galveston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transpulmonary Pressure-Guided Individualized PEEP","EXPERIMENTAL","A transpulmonary-guided individualized positive end-expiratory pressure (PEEPPTP) will be set as follows: (A) The intervention is initiated by a recruitment maneuver consisting of 5 cmH2O-stepwise (30 sec) PEEP increases until either maximum PEEP=30 cmH2O or end-inspiratory PTP\\>25 cmH2O is reached. Settings: volume-controlled ventilation, VT=7ml\u002Fkg, I:E=1:1, inspiratory pause=20%, RR=10bpm, FiO2=80%. (B) Following recruitment, PEEP will be set to the value used immediately before the recruitment maneuver and PEso-EE assessed.\n\nPEEPPTP=PEso-EE+1-2 cmH2O. (C) PEEP will then be set for 30 sec at the highest value achieved during recruitment, followed by (D) PEEPPTP. Individualized PEEP-setting will be performed after: (1) induction of anesthesia, (2) pneumoperitoneum and final surgical position, including Trendelenburg and robot docking, (3) significant airway pressure changes or \\>15% reduction in compliance (CRS=VT\u002FDP), and (4) before extubation.",[13],"Procedure: Standard PEEP (8 cmH₂O)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group - Standard Intraoperative PEEP","NO_INTERVENTION","PEEP will be set to currently accepted settings for intraoperative PEEP=8cmH2O.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Standard PEEP (8 cmH₂O)","Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure.",[9],[26],{"name":27,"affiliation":28,"role":29},"Marcos Vidal Melo","University of Texas Medial Branch","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Negar Motayagheni","CONTACT","(409)772-1011","nemotaya@utmb.edu",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"Congli Zeng, MD, PhD","cozeng@utmb.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Texas Medical Branch, Galveston","RECRUITING","Galveston","Texas","77555","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-94.7977,29.30135,{"lat":52,"lon":51},[55],{"name":32,"role":33,"phone":18,"phoneExt":18,"email":35},{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100652517","mechanical-ventilation-in-obese-surgical-patients-100652517",false,"NCT07774065","Mechanical Ventilation in Obese Surgical Patients","Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg\u002Fm2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Body Mass Index (BMI) ≥ 35 kg\u002Fm2;\n3. Scheduled for laparoscopic surgery expected to exceed 2h (from incision to closure) under general anesthesia, as determined pre-operatively by the attending surgeon and surgical team based on typical scheduling estimates, prior experience, procedure type, planned surgical approach, and patient-specific factors.\n\nExclusion Criteria:\n\n1. Previous lung surgery;\n2. Invasive mechanical ventilation for \\>30 minutes within the last 30 days prior to surgery;\n3. Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery;\n4. Neurological procedures or cardiac surgery;\n5. Need for one-lung ventilation or planned re-intubation following surgery;\n6. Requirement for intraoperative prone or lateral decubitus positioning;\n7. Enrollment in another interventional study or refusal to give written informed consent;\n8. Pregnancy, determined by anamnesis and\u002For laboratory testing;\n9. Persistent hemodynamic instability or intractable shock, considered hemodynamically unsuitable for the study by the patient's managing physician;\n10. Severe chronic obstructive pulmonary disease (COPD, defined as non-invasive ventilation and\u002For oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD);\n11. Severe cardiac disease (defined as New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia);\n12. Acute respiratory distress syndrome (according to the Berlin definition 2) expected to require prolonged postoperative mechanical ventilation;\n13. Severe pulmonary arterial hypertension (defined as systolic pulmonary artery pressure \\> 40 mmHg)\n14. Intracranial injury, intracranial tumor, or neuromuscular disease;\n15. Known esophageal disease or anatomy that would preclude the safe placement of a standard orogastric tube","ALL","18 Years",{"count":68,"type":69},10,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this study is to evaluate whether an intraoperative positive end-expiratory pressures (PEEP) setting strategy aimed at minimizing the mechanical power delivered to the lungs via transpulmonary pressure improves postoperative outcomes in obese patients undergoing conventional laparoscopic or robotic-assisted surgery. The objectives are to determine whether this strategy reduces immediate postoperative hypoxemia, and to assess whether it mitigates lung injury as reflected by relevant blood biomarkers.",[75],"Obese",[77,78,79,80],"Robotic Surgery","Body Mass Index (BMI) ≥ 35 kg\u002Fm2","Laparoscopic Surgery","Obesity","2026-08-14",{"date":83,"type":84},"2026-08-19","ACTUAL",{"date":86,"type":84},"2026-07-29",{"date":88,"type":69},"2027-07-31",{"name":5,"class":6},1]