Obese
Conditions
Keywords
Robotic Surgery, Body Mass Index (BMI) ≥ 35 kg/m2, Laparoscopic Surgery, Obesity
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.
Interventions
PROCEDUREStandard 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Oxygen Saturation (SpO₂) Following Extubation | 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 (%). |
| Fraction of Inspired Oxygen (FiO₂) Following Extubation | 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 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Highest Severity of Postoperative Pulmonary Complication (PPC) | 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. |
| Incidence of Grade 3 and Grade 4 Postoperative Pulmonary Complications | 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. |
| Duration of Postoperative Respiratory Support | 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. |
Countries
United States
Contacts
CONTACTNegar Motayagheni
CONTACTCongli Zeng, MD, PhD
PRINCIPAL_INVESTIGATORMarcos Vidal Melo
University of Texas Medial Branch
Outcome results
None listed