Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Transpulmonary Driving Pressure
研究概览
简要总结
The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
- •Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
- •Triggering breaths on the ventilator
- •Treating medical team agrees with patient participation
排除标准
- •Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
- •Shock that requires ≥ 2 vasopressors
- •pH on arterial blood gas ≤7.25
- •Minute ventilation ≥ 14L/min
- •Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
- •Severe ARDS with P/F ratio <60
- •Pregnancy
- •Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
- •Decision to withhold life-sustaining treatment
- •Patients who are not expected to survive for 24 hours
- •Lack of informed consent
研究组 & 干预措施
ARDS Patients Intubated on Mechanical Ventilation
ARDS patients in the ICU who are intubated on mechanical ventilation will be included. During ventilation, an esophageal catheter will be used to measure the esophageal pressure, which estimates pleural pressure at the level of the catheter. The esophageal catheter's position will be confirmed by a chest radiograph once inserted. The ventilator settings may be changed to see if these ventilator adjustments can reduce potential lung stress in ARDS patients. There is no set criteria for adjusting the ventilator settings based on the study device, but the goal would be to adjust the volume until the inspiratory effort measured by the catheter disappears so as to protect the patient. A one-to-two-hour study session will be performed for data collection. The esophageal catheter will be removed at the end of the study session or can be left in place for use as a feeding tube if needed for patient care.
干预措施: Esophageal Catheter (Other)
结局指标
主要结局
Transpulmonary Driving Pressure
时间窗: Up to Hour 2 (Day 1)
Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.
Driving Pressure
时间窗: Up to Hour 2 (Day 1)
Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.
Work of Breathing (WOB)
时间窗: Up to Hour 2 (Day 1)
WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.
Pressure-Time Product (PTP)
时间窗: Up to Hour 2 (Day 1)
PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.
次要结局
- Lung Compliance (C, l)(Up to Hour 2 (Day 1))
- Respiratory System Compliance (C, rs)(Up to Hour 2 (Day 1))
- Chest Wall Compliance (C, cw)(Up to Hour 2 (Day 1))
- Oxygen Saturation(Up to Hour 2 (Day 1))
- PaO2/FiO2 (P/F) Ratio(Up to Hour 2 (Day 1))