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Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
University of Texas Medical Branch, Galveston
RECRUITING
Galveston
Contact Information
Primary
Negar Motayagheni
nemotaya@utmb.edu
(409)772-1011
Backup
Congli Zeng, MD, PhD
cozeng@utmb.edu
(409)772-1011
Time Frame
Start Date: 2026-07-29
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Medical Branch, Galveston

This content was sourced from clinicaltrials.gov

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