Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Peripheral Oxygen Saturation (SpO₂) Following Extubation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 estimates, prior experience, procedure type, planned surgical approach, and patient-specific factors.
排除标准
- •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 interventional 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
结局指标
主要结局
Peripheral Oxygen Saturation (SpO₂) Following Extubation
时间窗: 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
时间窗: 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 (%).
次要结局
- Highest Severity of Postoperative Pulmonary Complication (PPC)(Postoperative Day 7 or hospital discharge, whichever occurs first)
- Incidence of Grade 3 and Grade 4 Postoperative Pulmonary Complications(Within 30 days after surgery)
- Duration of Postoperative Respiratory Support(From surgery until discontinuation of supplemental oxygen therapy and/or respiratory support, up to 30 days postoperatively)