Clinical trial for Obese
Official title Mechanical Ventilation in Obese Surgical Patients
ClinicalTrials.gov ID: NCT07774065
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Body Mass Index (BMI) ≥ 35 kg/m2;
- Scheduled for laparoscopic surgery expected to exceed 2h (from incision to closure) under general anesthesia, as determined pre-operatively by the...
You likely can't join if
- Previous lung surgery;
- Invasive mechanical ventilation for \>30 minutes within the last 30 days prior to surgery;
- Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery;
- Neurological procedures or cardiac surgery;
- Need for one-lung ventilation or planned re-intubation following surgery;
- Requirement for intraoperative prone or lateral decubitus positioning;
See the full eligibility criteria
- Age ≥ 18 years;
- Body Mass Index (BMI) ≥ 35 kg/m2;
- 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...
- Previous lung surgery;
- Invasive mechanical ventilation for \>30 minutes within the last 30 days prior to surgery;
- Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery;
- Neurological procedures or cardiac surgery;
- Need for one-lung ventilation or planned re-intubation following surgery;
- Requirement for intraoperative prone or lateral decubitus positioning;
- Enrollment in another treatment study or refusal to give written informed consent;
- Pregnancy, determined by anamnesis and/or laboratory testing;
- Persistent hemodynamic instability or intractable shock, considered hemodynamically unsuitable for the study by the patient's managing physician;
- 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);
- Severe cardiac disease (defined as New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia);
- Acute respiratory distress syndrome (according to the Berlin definition 2) expected to require prolonged postoperative mechanical ventilation;
- Severe pulmonary arterial hypertension (defined as systolic pulmonary artery pressure \> 40 mmHg)
- Intracranial injury, intracranial tumor, or neuromuscular disease;
- Known esophageal disease or anatomy that would preclude the safe placement of a standard orogastric tube
The study team makes the final eligibility decision.
Where it's taking place
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.