NCT06287632Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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: 1. 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? 2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia? Participants 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. * Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure * Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Feb 2024
- Start date
- Jun 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity
- NCT number
- NCT06287632
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Jun 2026 to the primary completion date, Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Respiratory insufficiency in PACU defined as:
- Respiratory rate \> 30
- Oxygen saturation \< 92%
- Receiving \> 6 liters of supplemental oxygen
Other illness
- Hemodynamic instability at the time of study assessment in the PACU defined as:
- systolic blood pressure \<90 mmHg or \>180 mmHg
- mean blood pressure \<60 or \>130 mmHg
- Any use of intravenous vasoactive agent
- heart rate \< 50 or \> 120 beats per minute
- Known chronic lung disease requiring supplemental oxygen at home
- Contraindication for electrical impedance tomograph belt placement:
- Pacemaker and/or internal cardiac defibrillator
- Chest skin injury
Lab values
- Known systolic heart dysfunction (left ventricular ejection fraction ≤ 30%)
- Contraindication for esophageal catheter placement:
- Known esophageal varices
- Known bacterial sinusitis
- Recent esophageal, nasopharyngeal, or laryngeal trauma or surgery
- Known coagulopathy: including history of thrombocytopenia defined as platelet count \<50,000; 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)
Other
- Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax
- Concern for study inclusion by the perioperative nurse or anesthesia team
Who the study is looking for
- Adult patients (≥ 18 years old) scheduled for elective non-cardiothoracic surgery requiring general anesthesia with an endotracheal tube
- Planned admission to the post-anesthesia care unit (PACU) after surgery
- BMI ≥ 40 kg/m2
- At the time of baseline measurements in the PACU, patients meet the following criteria:
- Receiving ≤ 6 liters of supplemental nasal cannula oxygen
- Alert as defined by a Richmond Agitation Sedation Scale of 0 or -1
- Oriented to person, place, and time
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.