NOT_YET_RECRUITING
Effect of Transpulmonary Pressure Guided Ventilation on Intraoperative Right Heart Function
The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart. In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings. Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs. For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded. For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery. A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed. Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.
Conditions:
🦠 Obesity 🦠 Surgery 🦠 Anesthesia 🦠 Echocardiography, Transesophageal 🦠 Mechanical Ventilation
🗓️ Study Start (Actual) 30 January 2023
🗓️ Primary Completion (Estimated) 15 October 2025
✅ Study Completion (Estimated) 15 March 2026
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Burlington, Vermont, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients undergoing robotic-assisted laparoscopic surgery at University of Vermont Medical Center in Trendelenburg position
    • * Age ≥ 18 years
    • * Signed consent form

    Exclusion Criteria:

    • * Inability to sign consent form
    • * Inability to speak English
    • * Emergent surgery
    • * Current smoker
    • * Smoking history ≥20 pack years
    • * Esophageal pathology: Strictures, varices, history of esophageal dilatation or surgery
    • * Intrinsic lung disease (e.g. asthma, COPD, emphysema, interstitial lung disease, lung cancer)
    • * Impaired cardiac function (e.g. decreased ejection fraction, wall motion abnormalities, or cardiomyopathy).
    • * Any other co-morbid condition that, in the opinion of the study investigators, may interfere with study participation.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 January 2023
  • First Submitted that Met QC Criteria 23 January 2023
  • First Posted 1 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 January 2023
  • Last Update Posted 1 February 2023
  • Last Verified January 2023