[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624414":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":44,"collaborators":43,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":43,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":75,"whyStopped":43,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":43},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"APRV Ventilation Strategy Group","EXPERIMENTAL","Intervention Name: Airway Pressure Release Ventilation (APRV) Patients will receive airway pressure release ventilation immediately upon admission to the intensive care unit following elective cardiac surgery. APRV will be applied as the primary ventilatory mode until the patient fulfills predefined extubation readiness criteria. Prior to extubation, patients will be transitioned to continuous positive airway pressure (CPAP) with pressure support or a T-piece trial for 15-30 minutes according to ICU protocol.",[13],"Device: Airway Pressure Release Ventilation (APRV)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Lung-Protective Ventilation Group","ACTIVE_COMPARATOR","Patients will receive conventional lung-protective mechanical ventilation using synchronized intermittent mandatory ventilation (SIMV) in volume-controlled mode with a tidal volume of 6-8 mL\u002Fkg of ideal body weight and high positive end-expiratory pressure upon admission to the intensive care unit. Ventilation will be continued until extubation readiness criteria are met, followed by a CPAP with pressure support or T-piece trial for 15-30 minutes prior to extubation.",[19],"Device: Conventional Lung-Protective Mechanical Ventilation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Airway Pressure Release Ventilation (APRV)","Patients will be ventilated using the Airway Pressure Release Ventilation (APRV) mode immediately upon ICU admission. This mode will be maintained throughout the postoperative period until the patient meets the clinical criteria for extubation. with the following standardized steps:\n\nInitial APRV Settings\n\n* P High: 20-25 cm H₂O\n* P Low: 0 cm H₂O\n* T High: 4.0-6.0 seconds\n* T Low: 0.5-0.8 seconds\n* FiO₂: Adjusted to maintain SpO₂ \\>92% Note: P High may be titrated according to patient tolerance, Mean airway pressure (MAP), and plateau pressures. T Low is set to terminate expiratory flow at 50-75% to preserve lung recruitment.\n\nWeaning\u002FTransition from APRV to Extubation Once oxygenation and ventilation criteria are met:\n\n* T High will be gradually increased (to ≥8 sec) and P High decreased (to 10-15 cm H₂O)\n* Then transition to CPAP\u002FPS for 15-30 minutes Final decision for extubation will be based on successful spontaneous breathing trial (SBT) (RSBI \\\u003C 105) and clinical readiness",[9],[27],"APRV",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Conventional Lung-Protective Mechanical Ventilation","Patients will be ventilated using the SIMV Volume-Controlled mode with lung-protective strategies:\n\n* Tidal volume: 6-8 mL\u002Fkg of Ideal Body Weight (IBW)\n* PEEP: Set at 8-12 cm H₂O, individualized based on oxygenation status\n* Respiratory rate: Adjusted to maintain normocapnia, typically starting from 12-18 breaths per minute\n* FiO₂: Titrated to maintain SpO₂ \\> 92%\n* Also transition to CPAP\u002FPS for 15-30 minutes as a transition before extubation will be applied.",[15],[33],"SIMV Volume-Controlled Ventilation",[35],{"name":36,"affiliation":5,"role":37},"Aya M Abbas, M.B.B.CH., M.Sc","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":41,"email":42},"CONTACT","+201157115835","ayaaabbass75@gmail.com",null,{"type":45,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100624414","prophylactic-use-of-aprv-before-extubation-in-morbidly-obese-patients-after-cardiac-surgery-100624414",false,"NCT07409324","Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery.","Prophylactic Use of Airway Pressure Release Ventilation (APRV) Prior to Extubation in Morbidly Obese Patients Undergoing Elective Cardiac Surgery: Impact on Pulmonary Function, Oxygenation, and ICU Outcomes.","APRV-OBESE-CS","Inclusion Criteria:\n\nAdult patients aged 18-65 year of both sex.\n\nMorbidly obese patients (body mass index ≥ 40 kg\u002Fm² or ≥ 35 kg\u002Fm² with obesity-related comorbidities)\n\nScheduled for elective cardiac surgery (CABG, valve, or combined) requiring cardiopulmonary bypass\n\nPlanned postoperative admission to the cardiac surgical intensive care unit\n\nPatients eligible for mechanical ventilation with planned early extubation within 6-12 hours postoperatively\n\nAbility to provide written informed consent\n\nExclusion Criteria:\n\nSevere pulmonary disease (e.g., COPD GOLD III\u002FIV, home oxygen therapy, and pulmonary fibrosis).\n\nPatients with history of previous spontaneous pneumothorax or postoperative pneumothorax.\n\nIntracranial hypertension or contraindication to APRV. Hemodynamically unstable on admission (MAP less than 65 mmHg) Vasopressor\u002Finotropic score (VIS) more than 10 Requirement for postoperative extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP).\n\nInability to obtain informed consent","ALL","18 Years","65 Years",{"count":58,"type":59},180,"ESTIMATED","INTERVENTIONAL",[62],"NA","Morbidly obese patients undergoing open heart surgery are at increased risk of breathing problems after removal of the breathing tube due to reduced lung function and chest wall restriction following surgery. These complications may result in poor oxygenation, respiratory failure, and prolonged ICU stay.\n\nAirway Pressure Release Ventilation (APRV) is a mechanical ventilation mode that improves lung recruitment and oxygenation. This study aims to evaluate whether the prophylactic use of APRV after ICU admission, compared with conventional lung-protective mechanical ventilation, improves oxygenation, lung function, and ICU outcomes in morbidly obese patients undergoing elective cardiac surgery.\n\nPatients will be randomly assigned to receive either APRV or conventional ventilation during postoperative mechanical ventilation, followed by standard weaning and extubation. Outcomes include oxygenation index, lung ultrasound findings, need for reintubation, and ICU clinical outcomes.",[65,66,67],"Morbid Obesity in Cardiac Surgery Patients","Postoperative Respiratory Dysfunction","Mechanical Ventilation Strategies",[69,70,71,72,73,74],"Airway Pressure Release Ventilation","Morbid Obesity","Cardiac Surgery","Postoperative Ventilation","Lung Ultrasound","Oxygenation","NOT_YET_RECRUITING","2026-02-08",{"date":78,"type":79},"2026-02-13","ACTUAL",{"date":81,"type":59},"2026-02-01",{"date":83,"type":59},"2026-11",{"name":5,"class":6}]