Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator.
The 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted/controlled mode and weaning under partial pressure support or volume support, followed by monitoring period until ICU discharge, hospital discharge or 30 days.
The study design differentiates between a Validation Cohort (up to 20 participants) for device validation and a Study Cohort (up to 61 participants) for safety and performance confirmation.
Serious Adverse Events related to study device and/or its procedure is defined as the primary safety endpoint, whereas technical failure rate is defined as the primary performance endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Participants ≥ 18 years of age at the time of consent.
- •Participants requiring invasive mechanical ventilation for a period of ≥3 hours.
- •Participants must provide written informed consent.
排除标准
- •Participants requiring anesthetic delivery systems or aerosol nebulizer systems.
- •Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO).
- •Any participant determined by the research team to be hemodynamically unstable, defined as:
- •MAP < 65 mmHg despite vasoactive drugs.
- •Systolic Blood Pressure > 180 mmHg.
- •Diastolic Blood Pressure > 110 mmHg.
- •Severe volume loss (>30% of blood volume) with persistent signs of hypoperfusion.
- •Life expectancy of less than 12 months.
- •Pregnant women at the time of informed consent.
研究组 & 干预措施
INBENTUS VERSATILE ventilation according to protocol specifications
干预措施: INBENTUS VERSATILE (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: From 3 to 48 hours of mechanical ventilation under the study device
Serious adverse events related to INBENTUS VERSATILE is defined as the primary safety endpoint
Primary Performance Endpoint
时间窗: From 3 to 48 hours of mechanical ventilation under the study device
Technical failure rate of INBENTUS VERSATILE is defined as the primary performance endpoint
次要结局
未报告次要终点