Registry for Automated Mechanical VEntilation in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- The primary safety endpoint is determinate by the percentage of breaths outside of the optimal and the acceptable zone during the observation period, based on the following ventilation parameters if available:
研究概览
简要总结
The aim of the here proposed study is to assess safety, performance and provide real world evidence (RWE) of the Hamilton Medical AG automated mechanical ventilation software packages in consecutive critically ill patients admitted to the intensive care unit.
详细描述
The harmful effect of invasive mechanical ventilation can be prevented by intensive training of ICU physicians, respiratory therapists, and ICU nurses on the one hand, and by improvement of the technology installed in ventilators on the other hand. Advanced mechanical ventilation modes use new technologies to assist physiology, optimize gas exchange and minimize ventilator induced lung injury. Modes such as proportional assist ventilation and neuronally adjusted ventilatory assist deliver assisted ventilation proportional to the patient's effort, improving ventilator patient synchrony. The Adaptive Support Ventilation (ASV) mode automatically adjust tidal volume and respiratory rate based on patient's respiratory mechanics to protect from mechanical ventilator induced lung injury, hence deliver safe mechanical ventilation. The implementation of advanced closed-loop systems automates medical reasoning and has potential to improve patient ventilator interactions, the time spent on mechanical ventilation, staff workload and potentially outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.
排除标准
- •Expected to be weaned from HFNO, NIV within 2 hours. Expected to be weaned and extubated from IMV without subsequent need of HFNO or NIV support within 2 hours.
- •Expected to be transferred to another non-participating ICU within 2 hours. Moribund subject: death expected within 2 hours.
研究组 & 干预措施
One cohort of consecutive patients
One cohort of consecutive patients admitted to the intensive care unit while on IMV or in need of HFNO, NIV lung support due to acute respiratory failure.
干预措施: Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen (Device)
结局指标
主要结局
The primary safety endpoint is determinate by the percentage of breaths outside of the optimal and the acceptable zone during the observation period, based on the following ventilation parameters if available:
时间窗: Day 0 - Day 7
Tidal volume (VT), maximum pressure (Pmax), oxygen saturation measured by pulse oximetry (SpO2), end-tidal partial pressure of carbon dioxide (PetCO2), Respiratory rate (RR) for spontaneous breathing subjects, Pmax-PEEP for passive ARDS subjects, driving pressure, mechanical power. The optimal and sub-optimal ranges are defined by current recommendations for different clinical conditions including normal lungs, brain injury, ARDS, and chronic hypercapnia.
The efficiency endpoint is determinate by the percentage of breath inside of the optimal zone during the observation period based on the following ventilation parameters if available:
时间窗: Day 0 - Day 7
tidal volume (VT), maximum pressure (Pmax), oxygen saturation measured by pulse oximetry (SpO2), end-tidal partial pressure of carbon dioxide (PetCO2), Respiratory rate (RR) for spontaneous breathing subjects, Pmax-PEEP for passive ARDS subjects, driving pressure, mechanical power. The optimal and sub-optimal ranges are defined by current recommendations for different clinical conditions including normal lungs, brain injury, ARDS, and chronic hypercapnia.
次要结局
未报告次要终点