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Search / Trial NCT06287632

CPAP in Patients With Severe Obesity After Anesthesia

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 23, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Clinical Trial Crossover Studies Continuous Positive Airway Pressure Electrical Impedance Tomography Esophageal Pressure Monitoring Transthoracic Echocardiography

ClinConnect Summary

This clinical trial is looking at how different settings of continuous positive airway pressure (CPAP) can help improve heart and lung function in patients with severe obesity after they have undergone anesthesia for surgery. Specifically, the study aims to find out if a special breathing technique combined with CPAP set to match pressure in the chest is more effective than standard CPAP settings. It will also explore whether the location of body fat affects how well these CPAP settings work.

To be eligible for the trial, participants must be adults over 18 years old with a body mass index (BMI) of 40 or higher, scheduled for certain types of surgery that require general anesthesia. They should be stable and alert after surgery and will be monitored for their breathing and heart function using special equipment. During recovery, participants will try two different CPAP settings for 20 minutes each. It’s important to note that not everyone will qualify, as certain medical conditions and current health statuses may exclude individuals from participation.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adult patients (≥ 18 years old) scheduled for elective non-cardiothoracic surgery requiring general anesthesia with an endotracheal tube
  • 2. Planned admission to the post-anesthesia care unit (PACU) after surgery
  • 3. BMI ≥ 40 kg/m2
  • 4. 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
  • Exclusion Criteria:
  • 1. Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax
  • 2. 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
  • 3. Respiratory insufficiency in PACU defined as:
  • Respiratory rate \> 30
  • Oxygen saturation \< 92%
  • Receiving \> 6 liters of supplemental oxygen
  • 4. Known chronic lung disease requiring supplemental oxygen at home
  • 5. Known systolic heart dysfunction (left ventricular ejection fraction ≤ 30%)
  • 6. 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)
  • 7. Contraindication for electrical impedance tomograph belt placement:
  • Pacemaker and/or internal cardiac defibrillator
  • Chest skin injury
  • 8. Concern for study inclusion by the perioperative nurse or anesthesia team

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

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Timeline

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Trial launched

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Estimated completion

Not reported