An interventional study of Standard PEEP (8 cmH₂O) in Obese, sponsored by The University of Texas Medical Branch, Galveston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Procedure: Standard PEEP (8 cmH₂O)
PEEP will be set to currently accepted settings for intraoperative PEEP=8cmH2O.
Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure.
Peripheral Oxygen Saturation (SpO₂) Following Extubation
Peripheral oxygen saturation (SpO₂) will be measured by pulse oximetry at least every 15 minutes during the first hour following extubation. SpO₂ will be recorded as a percentage (%).
Time frame: First hour following extubation (assessed at least every 15 minutes)
Fraction of Inspired Oxygen (FiO₂) Following Extubation
Fraction of inspired oxygen (FiO₂) will be recorded at least every 15 minutes during the first hour following extubation. FiO₂ will be recorded as a percentage (%).
Time frame: First hour following extubation (assessed at least every 15 minutes)
Highest Severity of Postoperative Pulmonary Complication (PPC)
Highest severity grade of any postoperative pulmonary complication (PPC) experienced by the participant, assessed using the study-defined PPC severity classification.
Time frame: Postoperative Day 7 or hospital discharge, whichever occurs first
Incidence of Grade 3 and Grade 4 Postoperative Pulmonary Complications
Number of participants who experience Grade 3 or Grade 4 postoperative pulmonary complications (PPCs) based on the study-defined PPC severity classification.
Time frame: Within 30 days after surgery
Duration of Postoperative Respiratory Support
Duration of postoperative supplemental oxygen therapy and/or other respiratory support, including noninvasive or invasive respiratory support, measured from initiation to discontinuation.
Time frame: From surgery until discontinuation of supplemental oxygen therapy and/or respiratory support, up to 30 days postoperatively
Major Extrapulmonary Complications
Number of participants experiencing major extrapulmonary postoperative complications.
Time frame: Within 30 days after surgery
All-Cause Mortality
Number of all-cause mortality following surgery.
Time frame: Postoperative Day 30
Length of Stay in the Post-Anesthesia Care Unit (PACU)
Duration of stay in the post-anesthesia care unit following surgery.
Time frame: At 3 hours after PACU admission
Unexpected Intensive Care Unit (ICU) Admission
Number of participants requiring an unplanned admission to the Intensive Care Unit following surgery.
Time frame: During the index hospitalization, up to 30 days after surgery
Hospital Length of Stay
Duration of hospitalization following surgery.
Time frame: Day of surgery, postoperative Day 7, and postoperative Day 30, or discharge, whichever occurs first
ICU Length of Stay
Duration of stay in the Intensive Care Unit among participants admitted to the ICU postoperatively.
Time frame: Day of surgery, postoperative Day 7, and postoperative Day 30, or discharge, whichever occurs first
Immediate Postoperative Adverse Events
Number of adverse events occurring within 24 hours after surgery, including pneumothorax, hypoxemia, hypotension, use of vasoactive medications, and volume replacement.
Time frame: Within 24 hours after surgery
End-Inspiratory Transpulmonary Pressure Greater Than 25 cmH₂O
Rate of participants with end-inspiratory transpulmonary pressure (PTP) greater than 25 cmH₂O during the perioperative period.
Time frame: During surgery
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The University of Texas Medical Branch, Galveston