[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538192":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":41,"locations":32,"responsibleParty":50,"collaborators":32,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":32,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":32,"enrollmentInfo":63,"targetDuration":32,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":76,"overallStatus":83,"whyStopped":32,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":32},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Recruitment and ITP-CPAP","EXPERIMENTAL","Recruitment maneuver followed by CPAP set to intrathoracic pressure (ITP)",[13],"Device: Recruitment\u002FITP-CPAP (Intervention A)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard CPAP","ACTIVE_COMPARATOR","CPAP set to home level of CPAP (if known) or CPAP set to standard levels (8-10 cmH20)",[19],"Device: Standard CPAP (Intervention B)",{"label":21,"type":22,"description":23,"interventionNames":24},"Atmospheric pressure","PLACEBO_COMPARATOR","Breathing without CPAP",[25],"Device: Atmospheric Pressure",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Recruitment\u002FITP-CPAP (Intervention A)","Participant will receive a recruitment maneuver followed by CPAP set to the level of end-expiratory esophageal pressure (measured during atmospheric pressure breathing). The intervention will last for 20 minutes.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Standard CPAP (Intervention B)","Participant will receive their home CPAP (if on CPAP at home) or CPAP at 8-10 cmH20 (if not on CPAP at home or no known diagnosis of OSA). The intervention will last for 20 minutes.",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Atmospheric Pressure","Participant will breathe at atmosphere pressure (no CPAP) with supplemental oxygen as needed per clinical guidance.",[21],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":32,"email":46},"Timothy Gaulton, MD, MSc","CONTACT","617-643-7733","tgaulton@mgh.harvard.edu",{"name":48,"role":44,"phone":32,"phoneExt":32,"email":49},"Lorenzo Berra","lberra@mgh.harvard.edu",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Timothy G. Gaulton, MD","Member of the Faculty of Anesthesia","100538192","cpap-in-patients-with-severe-obesity-after-anesthesia-100538192",false,"NCT06287632","CPAP in Patients With Severe Obesity After Anesthesia","Assessment of Cardiopulmonary Function in Response to Continuous Positive Airway Pressure in Patients With Severe Obesity After Anesthesia","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) scheduled for elective non-cardiothoracic surgery requiring general anesthesia with an endotracheal tube\n2. Planned admission to the post-anesthesia care unit (PACU) after surgery\n3. BMI ≥ 40 kg\u002Fm2\n4. At the time of baseline measurements in the PACU, patients meet the following criteria:\n\n   * Receiving ≤ 6 liters of supplemental nasal cannula oxygen\n   * Alert as defined by a Richmond Agitation Sedation Scale of 0 or -1\n   * Oriented to person, place, and time\n\nExclusion Criteria:\n\n1. Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax\n2. Hemodynamic instability at the time of study assessment in the PACU defined as:\n\n   * systolic blood pressure \\\u003C90 mmHg or \\>180 mmHg\n   * mean blood pressure \\\u003C60 or \\>130 mmHg\n   * Any use of intravenous vasoactive agent\n   * heart rate \\\u003C 50 or \\> 120 beats per minute\n3. Respiratory insufficiency in PACU defined as:\n\n   * Respiratory rate \\> 30\n   * Oxygen saturation \\\u003C 92%\n   * Receiving \\> 6 liters of supplemental oxygen\n4. Known chronic lung disease requiring supplemental oxygen at home\n5. Known systolic heart dysfunction (left ventricular ejection fraction ≤ 30%)\n6. Contraindication for esophageal catheter placement:\n\n   * Known esophageal varices\n   * Known bacterial sinusitis\n   * Recent esophageal, nasopharyngeal, or laryngeal trauma or surgery\n   * Known coagulopathy: including history of thrombocytopenia defined as platelet count \\\u003C50,000; presence of hemophilia; known genetic disorder of coagulation (e.g.,deficits of protein C, protein S, von Willebrand factor) or oral and subcutaneous anticoagulation treatment (e.g., heparin, warfarin, and or other oral anticoagulants)\n7. Contraindication for electrical impedance tomograph belt placement:\n\n   * Pacemaker and\u002For internal cardiac defibrillator\n   * Chest skin injury\n8. Concern for study inclusion by the perioperative nurse or anesthesia team","ALL","18 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:\n\n1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?\n2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?\n\nParticipants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.\n\n* Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure\n* Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present).",[71,72,73,74,75],"Obesity, Abdominal","Anesthesia Morbidity","Apnea, Obstructive Sleep","Atelectases, Postoperative Pulmonary","Ventilator Lung",[77,78,79,80,81,82],"clinical trial","crossover studies","continuous positive airway pressure","electrical impedance tomography","esophageal pressure monitoring","transthoracic echocardiography","NOT_YET_RECRUITING","2025-11-17",{"date":86,"type":87},"2025-11-18","ACTUAL",{"date":89,"type":65},"2026-06",{"date":91,"type":65},"2027-06",{"name":5,"class":6}]