Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation Versus Conventional Management in Weaning Window Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ventilator-Free Days
研究概览
简要总结
This study aims to determine whether Airway Occlusion Pressure (P0.1) Guided Pressure Support Ventilation is superior to conventional management for patients in weaning windows.
详细描述
Mechanical ventilation is an essential modality for critically ill patients with acute respiratory failure. It supports gas exchange and reduces respiratory muscle workload, but prolonged use increases the risk of lung injury, diaphragm dysfunction, and infection. Therefore, the process of ventilator weaning is crucial in optimizing patient outcomes.
Airway occlusion pressure (P0.1), the negative pressure generated 100 ms after the onset of inspiration during an occluded breath, provides a direct measurement of patient respiratory drive independent of lung mechanics. It is a strong indicator of ventilatory demand and drive-load imbalance.
Pressure Support Ventilation (PSV) is commonly used during the weaning window, but conventional titration methods rely on clinical assessment alone. These methods do not reliably identify asynchronous events such as ineffective effort, double triggering, or premature cycling, which prolong ventilation.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated adult patients ≥ 21 years.
- •Patients on pressure support ventilation for at least 24 hours and clinically determined to be in the weaning window (transition between assisted ventilation and spontaneous ventilation) with improving respiratory status.
- •Hemodynamically stable [mean arterial pressure (MAP) ≥60 mmHg].
- •All patients will be required to have light sedation with a Richmond Agitation-Sedation Scale (RASS) score between -1 and 0 to allow reliable assessment of respiratory drive.
排除标准
- •Patients with neuromuscular disorders affecting respiratory drive
- •Glasgow Coma Scale (GCS) score below 8
- •Cervical spinal cord injury
- •Receipt of neuromuscular blockers within the previous 24 hours
- •Morbid obesity resulting in unreliable respiratory mechanics
- •Pregnancy
- •Deep sedation defined as RASS ≤ -2
- •Hemodynamic instability requiring escalating vasopressor support.
结局指标
主要结局
Ventilator-Free Days
时间窗: Day 28 after the procedure
Ventilator-Free Days (VFD) at Day 28, defined as the number of days a patient is free from mechanical ventilation within the first 28 days after randomization. VFD are calculated as 28 minus the total days on mechanical ventilation from Day 0 until successful extubation.
次要结局
- Duration of Mechanical Ventilation(Till final successful extubation (Up to 48 hours))
- Length of stay in the intensive care unit(Till the discharge from intensive care unit (Up to 28 days))
- Patient-Ventilator Asynchrony Index (PVAI)(Day 28 after the procedure)
- Dexmedetomidine requirement(Day 28 after the procedure)
- Failed weaning(48 hours after extubation)
研究者
Muhammad Ahmed Kandil
Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Egypt.
Tanta University