Mechanical Ventilation in Obese Surgical Patients

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT07774065
Status
Recruiting
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Conditions

  • Obese

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard PEEP (8 cmH₂O) — PROCEDURE
    Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Jul 29, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Transpulmonary Pressure-Guided Individualized PEEP
    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.
  • No Intervention: Control Group - Standard Intraoperative PEEP
    PEEP will be set to currently accepted settings for intraoperative PEEP=8cmH2O.

Primary Outcome Measure

Peripheral Oxygen Saturation (SpO₂) Following Extubation [ Time Frame: First hour following extubation (assessed at least every 15 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical Branch, GalvestonGalvestonTexas77555
Negar Motayagheni
[email protected]

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University of Texas Medical Branch, Galveston· Galveston, TX

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