University of Texas Medical Branch, Galveston
Galveston, Texas, 77555, United States
Location status: Recruiting
NCT Number: NCT07774065
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Galveston, Texas, 77555, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure.
Time frame: First hour following extubation (assessed at least every 15 minutes)
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) will be recorded at least every 15 minutes during the first hour following extubation. FiO₂ will be recorded as a percentage (%).
Time frame: Postoperative Day 7 or hospital discharge, whichever occurs first
Highest severity grade of any postoperative pulmonary complication (PPC) experienced by the participant, assessed using the study-defined PPC severity classification.
Time frame: Within 30 days after surgery
Number of participants who experience Grade 3 or Grade 4 postoperative pulmonary complications (PPCs) based on the study-defined PPC severity classification.
Time frame: From surgery until discontinuation of supplemental oxygen therapy and/or respiratory support, up to 30 days postoperatively
Duration of postoperative supplemental oxygen therapy and/or other respiratory support, including noninvasive or invasive respiratory support, measured from initiation to discontinuation.
Time frame: Within 30 days after surgery
Number of participants experiencing major extrapulmonary postoperative complications.
Time frame: Postoperative Day 30
Number of all-cause mortality following surgery.
Time frame: At 3 hours after PACU admission
Duration of stay in the post-anesthesia care unit following surgery.
Time frame: During the index hospitalization, up to 30 days after surgery
Number of participants requiring an unplanned admission to the Intensive Care Unit following surgery.
Time frame: Day of surgery, postoperative Day 7, and postoperative Day 30, or discharge, whichever occurs first
Duration of hospitalization following surgery.
Time frame: Day of surgery, postoperative Day 7, and postoperative Day 30, or discharge, whichever occurs first
Duration of stay in the Intensive Care Unit among participants admitted to the ICU postoperatively.
Time frame: Within 24 hours after surgery
Number of adverse events occurring within 24 hours after surgery, including pneumothorax, hypoxemia, hypotension, use of vasoactive medications, and volume replacement.
Time frame: During surgery
Rate of participants with end-inspiratory transpulmonary pressure (PTP) greater than 25 cmH₂O during the perioperative period.
Contact information is provided by the study sponsor or research team.
Congli Zeng, MD, PhD
CONTACT
Negar Motayagheni
CONTACT
The University of Texas Medical Branch, Galveston
Other
Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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