Evaluation of Beacon Care System Advice in Pressure Support: Does the System Maintain Patients Within Appropriate Levels of Support?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Reduction of respiratory fatigue of patient under mechanical ventilation
研究概览
简要总结
The aim of this study is to evaluate the ventilator settings advice given by the BEACON care system in fitting with best level of support in patient under mechanical ventilation in Pressure Support mode.
详细描述
The purpose of this study is to evaluate whether pressure support settings suggested by the B3 system and pressure support as well as Positive End Expiratory Pressure (PEEP) settings suggested by the B5 system, i.e. balancing under and over support based upon physiological models and simple clinical measures, are consistent with keeping patients within appropriate levels of support as assessed by the ratio between airwaiy pressure generated by the respiratory muscles (Pmus) and the maximum inspiratory pressure (MIP) (Pmus/MIP), the ratio between the inspiratory time (TI) and total respiratory time (TTOT) (TI/TTOT) and the Tension-Time index (TTi), these being obtained using less frequently used esophageal catheter measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Under mechanical ventilation in Pressure Support mode
排除标准
- •Neuromuscular impairment
研究组 & 干预措施
Pressure Support Under Support
Pressure Support Level downward by 50%, 2 hours
干预措施: Pressure Support Over Support (Device)
Pressure Support Over Support
Pressure Support Level upward by 50%, 2 hours
干预措施: Pressure Support Over Support (Device)
Pressure Support Over Support
Pressure Support Level upward by 50%, 2 hours
干预措施: Pressure Support Under Support (Device)
Pressure Support Under Support
Pressure Support Level downward by 50%, 2 hours
干预措施: Pressure Support Under Support (Device)
PEEP Over Level
PEEP Level upward by 50%, 2 hours
干预措施: PEEP Over Level (Device)
PEEP Over Level
PEEP Level upward by 50%, 2 hours
干预措施: PEEP Under Level (Device)
PEEP Under Level
PEEP Level downward by 50%, 2 hours
干预措施: PEEP Over Level (Device)
PEEP Under Level
PEEP Level downward by 50%, 2 hours
干预措施: PEEP Under Level (Device)
结局指标
主要结局
Reduction of respiratory fatigue of patient under mechanical ventilation
时间窗: Average of 1 hour
Esophageal catheter will be positioned and pressure generated by the respiratory muscles will be measured to detect respiratory muscles' fatigue.
次要结局
未报告次要终点
研究者
Savino Spadaro
Assistant Professor - Researcher
Università degli Studi di Ferrara