Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of conducting a definitive trial (composite)
研究概览
简要总结
This protocol describes a randomized controlled feasibility vanguard study designed to investigate the implementation and effects of esophageal pressure-guided positive end-expiratory pressure (PEEP) titration in patients with high body mass index (BMI) mechanically ventilated patients at the Edmonton Zone. The study will enroll 30 patients with body mass index (BMI) >=30 kg/m2 who require invasive mechanical ventilation, randomizing them in a 1:1 ratio to receive either esophageal pressure-guided PEEP titration or standard care management. The primary objective focuses on establishing the feasibility of conducting a larger definitive trial, while secondary objectives examine differences in applied PEEP levels, respiratory mechanics, and clinical outcomes between groups. The intervention protocol targets end-expiratory transpulmonary pressure of 0-2 cmH2O.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 or older
- •Body mass index ≥30 kg/m²
- •Intubated and receiving passive mechanical ventilation
- •Within 24 hours of intubation
- •Anticipated need for mechanical ventilation for at least 48 hours
排除标准
- •Known or suspected esophageal varices
- •Esophageal surgery within 3 months
- •Known esophageal stricture or perforation
- •Active upper gastrointestinal bleeding
- •Severe coagulopathy (INR >3.0 or platelet count <30,000/μL)
- •Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (<20 mmHg)
- •Severe hemodynamic instability at treating physician discretion
- •Known pregnancy
- •Moribund state with expected survival <48 hours
- •Receiving extracorporeal membrane oxygenation (ECMO)
- •Open abdomen post-operatively
- •Previous enrollment in this study
- •Any other contraindication to esophageal balloon placement as determined by clinical team
研究组 & 干预措施
Esophageal-balloon guided
Esophageal balloon catheter placed within 4 hours of randomization. PEEP titrated to achieve end-expiratory transpulmonary pressure of 0-2 cmH2O (up to 8 cmH2O for P/F ratio <200). PEEP adjusted in 2 cmH2O increments with 5-minute stabilization periods. Safety limits: transpulmonary driving pressure <15 cmH2O, end-inspiratory transpulmonary pressure <20 cmH2O. Reassessment twice daily (approximately 0800 and 2200). Catheter removed prior to extubation or at 28 days, whichever occurs first.
干预措施: Esophageal pressure-guided PEEP titration (Procedure)
Standard of Care
PEEP management according to current standard practice. For patients meeting ARDS criteria, PEEP titrated using the ARDSNet PEEP/FiO2 table. For non-ARDS patients, PEEP titrated per local practice to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics. No esophageal pressure monitoring.
干预措施: Standard care PEEP management (Other)
结局指标
主要结局
Feasibility of conducting a definitive trial (composite)
时间窗: 14 months
Composite feasibility assessment including: (1) Recruitment rate (patients enrolled per month, target 1-1.5/month); (2) Successful esophageal catheter placement rate in intervention arm; (3) Protocol adherence (percentage of scheduled transpulmonary pressure measurements completed, compliance with PEEP titration algorithm); (4) Data completeness for average PEEP over 7 days.
次要结局
- Average PEEP(7 days)
- Driving Pressure(7 days)
- Partial oxygen pressure over inspired oxygen fraction ratio(7 days)
- Days alive and free of mechanical ventilation(Up to hospital discharge assessed up to 30 days)
- Days alive and outside the intensive care unit(Up to hospital discharge assessed up to 30 days)
- Hospital Mortality(Up to hospital discharge assessed up to 30 days)
- Hemodynamics Instability(Up to 7 days)