Adjusting Breathing Machine Pressure During Laparoscopic or Robotic Surgery in People With Obesity
Tests a ventilator pressure strategy to protect the lungs in adults with obesity having surgery.
Key facts
- Who runs it
- The University of Texas Medical Branch, Galveston
- Where
- Galveston, United StatesSee the site
- Trial code
- Registry title
- Mechanical Ventilation in Obese Surgical Patients
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- 29 Jul 2026
- Expected to end
- 31 Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Standard PEEP (8 cmH₂O)
- Record updated
- 19 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a body mass index of 35 kg/m2 or more who are having a long laparoscopic or robotic-assisted operation under general anesthesia.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Body Mass Index (BMI) 35 kg/m2 or higher. Scheduled laparoscopic surgery expected to last more than 2h under general anesthesia.
- Earlier treatment
- No machine breathing (invasive mechanical ventilation) for more than 30 minutes in the last 30 days. No chemotherapy or radiotherapy up to two months before surgery. No previous lung surgery.
Main reasons for not taking part
- Pregnancy
- Severe chronic obstructive pulmonary disease (COPD) or severe heart disease
- Neurological or cardiac surgery, or surgery needing one-lung ventilation
- Surgery needing prone or lateral decubitus (on the side) positioning
- Severe pulmonary arterial hypertension or acute respiratory distress syndrome
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Age ≥ 18 years
- Body Mass Index (BMI) ≥ 35 kg/m2
- Scheduled for laparoscopic surgery expected to exceed 2h (from incision to closure) under general anesthesia, as determined pre-operatively by the attending surgeon and surgical team based on typical scheduling estimates, prior experience, procedure type, planned surgical approach, and patient-specific factors
Who cannot take part
- Previous lung surgery
- Invasive mechanical ventilation for >30 minutes within the last 30 days prior to surgery
- Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery
- Need for one-lung ventilation or planned re-intubation following surgery
- Neurological procedures or cardiac surgery
- Severe chronic obstructive pulmonary disease (COPD, defined as non-invasive ventilation and/or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD)
- Severe cardiac disease (defined as New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia)
- Acute respiratory distress syndrome (according to the Berlin definition 2) expected to require prolonged postoperative mechanical ventilation
- Severe pulmonary arterial hypertension (defined as systolic pulmonary artery pressure > 40 mmHg)
- Intracranial injury, intracranial tumor, or neuromuscular disease
- Known esophageal disease or anatomy that would preclude the safe placement of a standard orogastric tube
- Pregnancy, determined by anamnesis and/or laboratory testing
- Requirement for intraoperative prone or lateral decubitus positioning
- Enrollment in another interventional study or refusal to give written informed consent
- Persistent hemodynamic instability or intractable shock, considered hemodynamically unsuitable for the study by the patient's managing physician
Where in United States
- University of Texas Medical Branch - GalvestonGalveston, United StatesContact: Negar MotayagheniTaking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate whether an intraoperative positive end-expiratory pressures (PEEP) setting strategy aimed at minimizing the mechanical power delivered to the lungs via transpulmonary pressure improves postoperative outcomes in obese patients undergoing conventional laparoscopic or robotic-assisted surgery. The objectives are to determine whether this strategy reduces immediate postoperative hypoxemia, and to assess whether it mitigates lung injury as reflected by relevant blood biomarkers.
The 2 groups in the trial
- Transpulmonary Pressure-Guided Individualized PEEPTreatment being tested
A transpulmonary-guided individualized positive end-expiratory pressure (PEEPPTP) will be set as follows: (A) The intervention is initiated by a recruitment maneuver consisting of 5 cmH2O-stepwise (30 sec) PEEP increases until either maximum PEEP=30 cmH2O or end-inspiratory PTP\>25 cmH2O is reached. Settings: volume-controlled ventilation, VT=7ml/kg, I:E=1:1, inspiratory pause=20%, RR=10bpm, FiO2=80%. (B) Following recruitment, PEEP will be set to the value used immediately before the recruitment maneuver and PEso-EE assessed. PEEPPTP=PEso-EE+1-2 cmH2O. (C) PEEP will then be set for 30 sec at the highest value achieved during recruitment, followed by (D) PEEPPTP. Individualized PEEP-setting will be performed after: (1) induction of anesthesia, (2) pneumoperitoneum and final surgical position, including Trendelenburg and robot docking, (3) significant airway pressure changes or \>15% reduction in compliance (CRS=VT/DP), and (4) before extubation.
Treatment: Standard PEEP (8 cmH₂O)
- Control Group - Standard Intraoperative PEEPNo study treatment, for comparison
PEEP will be set to currently accepted settings for intraoperative PEEP=8cmH2O.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery
- Plain-language title
- Adjusting Breathing Machine Pressure During Laparoscopic or Robotic Surgery in People With ObesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 19 August 2026