NCT07774065 Mechanical Ventilation in Obese Surgical Patients
| NCT ID | NCT07774065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Medical Branch, Galveston |
| Condition | Obese |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-07-29 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-07-29 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Marcos Vidal Melo
PRINCIPAL INVESTIGATOR
University of Texas Medial Branch
Frequently Asked Questions
Who can join the NCT07774065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obese. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07774065 currently recruiting?
Yes, NCT07774065 is actively recruiting participants. Contact the research team at nemotaya@utmb.edu for enrollment information.
Where is the NCT07774065 trial being conducted?
This trial is being conducted at Galveston, United States.
Who is sponsoring the NCT07774065 clinical trial?
NCT07774065 is sponsored by The University of Texas Medical Branch, Galveston. The principal investigator is Marcos Vidal Melo at University of Texas Medial Branch. The trial plans to enroll 10 participants.