The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony in Patients With Acute Respiratory Distress Syndrome: a Cross-Over Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.
研究概览
简要总结
Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Therefore, strategies to reduce patient-ventilator asynchrony need to be established promptly. Several asynchronies, e.g., breath stacking are caused by vigorous spontaneous breathing effort. Recently, the investigators' group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, the investigators conjectured that higher PEEP may reduce the intensity of spontaneous breathing effort and thereby reduce patient-ventilator asynchrony during protective ventilation strategy, compared with lower PEEP in patients with ARDS.
详细描述
The cross-over study will enroll 10 participants fulfilled with the criteria of Berlin definition of moderate-to-severe ARDS and under mechanical ventilation in intensive care unit (ICU) at Osaka University Hospital. Informed consent will be obtained by legal representatives. After obtaining informed consent, participants will be randomly assigned to one of two groups: "higher PEEP - lower PEEP" or "lower PEEP - higher PEEP". PEEP, either higher or lower, will be set according to higher or lower PEEP/FIO2 table. The depth of sedation will be monitored quantitively and maintained to be the same throughout the protocol. The intensity of spontaneous breathing activity will be assessed with esophageal balloon manometry and electrical activity of diaphragm. At each PEEP setting, asynchrony index will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants, their legal representatives, and outcomes assessor are blinded.
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
- •Patients ≧ 18 years old
- •Patients with moderate to severe ARDS under mechanical ventilation＊ ＊ Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 200 mmHg with PEEP ≧ 5 cmH2O)
排除标准
- •Lack of informed consent
- •Continuous neuromuscular blockade at enrollment
- •DNR (do-not-resuscitate)
- •Moribund patient not expected to survive 24 hours
- •Massive hemoptysis
- •Increased intracranial pressure (> 18 mmHg)
- •Existence or high risk of pneumothorax
- •Known pregnancy
- •Actual body weight exceeding 1 kg/cm
- •Patient judged to be inappropriate for the trial by intensivist
结局指标
主要结局
Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.
时间窗: Through study completion (up to 24 hours)
次要结局
- Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.(Through study completion (up to 24 hours))
- Minute volume at higher and lower PEEP(Through study completion (up to 24 hours))
- The efficiency of diaphragmatic contraction measured by electrical activity of diaphragm at higher and lower PEEP.(Through study completion (up to 24 hours))
- The intensity of spontaneous breathing effort measured by esophageal manometry at higher and lower PEEP(Through study completion (up to 24 hours))