Mechanical ventilation strategy to protect the lungs in obese adults during laparoscopic or robotic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates a targeted intraoperative PEEP strategy aimed at reducing the mechanical power delivered to the lungs by adjusting transpulmonary pressure. The goal is to see if this approach lowers immediate postoperative hypoxemia and reduces lung injury biomarkers in obese adults undergoing conventional laparoscopic or robotic-assisted surgery expected to last more than two hours. Standard PEEP of 8 cmH2O is used as the comparator. Eligible participants are adults with BMI ≥35 kg/m2 scheduled for long laparoscopic procedures under general anesthesia, with several medical exclusions to minimize risk. The trial is led by The University of Texas Medical Branch, Galveston, at its Galveston, TX site.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Texas Medical Branch, Galveston
  Galveston, Texas, United States Recruiting

Study contacts

• Principal investigator: Marcos Vidal Melo — University of Texas Medial Branch
• Study coordinator: Negar Motayagheni
• Email: nemotaya@utmb.edu
• Phone: (409)772-1011

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.