Mechanical Ventilation in Obese Surgical Patients
Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a breathing machine setting during surgery that aims to reduce the energy sent to the lungs. It checks whether this lowers low blood oxygen right after surgery and signs of lung injury in blood tests. It is for adults with obesity having surgery through small cuts, with or without a robot.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Body mass index (BMI), a measure of weight compared with height, of 35 or higher.
- Scheduled for surgery through small cuts that the surgery team expects to last more than 2 hours, under general anesthesia (medicine that keeps you asleep).
Who can't join
- Past lung surgery, or breathing machine use through a tube for more than 30 minutes in the 30 days before surgery.
- Treatment that weakens the immune system, listed as chemotherapy or radiation, within 2 months before surgery.
- Brain, nerve, or heart surgery; need to ventilate only one lung; a planned breathing tube after surgery; or need to lie face down or on your side during surgery.
- Pregnancy, being in another study that tests a treatment, or not agreeing in writing to join.
- Ongoing unstable blood flow or shock that your doctor considers unsafe for this study; or severe heart disease, including major limits on activity, sudden loss of blood flow to the heart, or an ongoing fast rhythm in the heart’s lower chambers.
- Severe COPD (long-term lung disease) needing home oxygen, breathing support through a mask, or repeated steroid treatment for flare-ups; or severe sudden lung injury expected to need long-term breathing machine support after surgery.
- Severe high blood pressure in the lung arteries, with a top pressure above 40 mmHg; an injury or tumor inside the skull; or a disease affecting nerves and muscles.
- A known problem with the food pipe or body structure that makes placing a standard tube from the mouth to the stomach unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
TX
- University of Texas Medical Branch, Galveston · Galveston, TX 77555Negar Motayagheni · Study contact · nemotaya@utmb.eduMore trials in Galveston