Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Transpulmonary pressure generate by patient during deep or light sedation
研究概览
简要总结
The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.
详细描述
Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
盲法说明
No Masking
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:
- •Requires positive pressure ventilation through an endotracheal tube
- •Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
- •PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days
- •No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)
- •Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)
排除标准
- •Age younger than 18 years or older than 85 years
- •Cardiac failure
- •Known pregnancy
- •Increased intracranial pressure
- •Severe neuromuscular disease
- •Recent injury or other pathologic condition of the esophagus
- •Pneumothorax
- •Pleural effusion
- •Diaphragmatic hernia
- •Severe chronic respiratory disease
- •End-stage chronic organ failure
- •Expected survival of less than 24 hours
- •Participation in another interventional study
- •Attending physician declines to give consent for participant to enroll
- •Patient or surrogate declines or is unable to give consent
研究组 & 干预措施
Deep sedation
In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously
干预措施: Deep sedated (Drug)
Light sedation
In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously
干预措施: Light sedated (Drug)
结局指标
主要结局
Transpulmonary pressure generate by patient during deep or light sedation
时间窗: 15 minutes during deep or light sedation
Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation
次要结局
- PaO2(15 minutes)
- static compliance of respiratory system(15min during deep or light sedation)
研究者
Songqiao Liu
Principal Investigator
Southeast University, China