Recruiting

PEEP Strategy

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07774065

Conditions

Obese

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard PEEP (8 cmH₂O)

Study Details

Brief 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.

Conditions

Obese

Study ID

NCT07774065

Start date

Jul 29, 2026

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years;
2. Body Mass Index (BMI) ≥ 35 kg/m2;
3. 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.

Exclusion Criteria:

1. Previous lung surgery;
2. Invasive mechanical ventilation for >30 minutes within the last 30 days prior to surgery;
3. Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery;
4. Neurological procedures or cardiac surgery;
5. Need for one-lung ventilation or planned re-intubation following surgery;
6. Requirement for intraoperative prone or lateral decubitus positioning;
7. Enrollment in another interventional study or refusal to give written informed consent;
8. Pregnancy, determined by anamnesis and/or laboratory testing;
9. Persistent hemodynamic instability or intractable shock, considered hemodynamically unsuitable for the study by the patient's managing physician;
10. 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);
11. Severe cardiac disease (defined as New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia);
12. Acute respiratory distress syndrome (according to the Berlin definition 2) expected to require prolonged postoperative mechanical ventilation;
13. Severe pulmonary arterial hypertension (defined as systolic pulmonary artery pressure > 40 mmHg)
14. Intracranial injury, intracranial tumor, or neuromuscular disease;
15. Known esophageal disease or anatomy that would preclude the safe placement of a standard orogastric tube

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Standard PEEP (8 cmH₂O)

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

Primary outcome measure

  • Peripheral Oxygen Saturation (SpO₂) Following Extubation [ Time Frame: First hour following extubation (assessed at least every 15 minutes) ]
  • Fraction of Inspired Oxygen (FiO₂) Following Extubation [ Time Frame: First hour following extubation (assessed at least every 15 minutes) ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Medical Branch, Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Negar Motayagheni

nemotaya@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Robotic Surgery
  • Body Mass Index (BMI) ≥ 35 kg/m2
  • Laparoscopic Surgery
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-08-19.