Open-labeled, Non-randomized, Self-controlled Study to Evaluate the Safety and Performance of EZVent in Hospitalized Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Comparable lung mechanics parameters
研究概览
简要总结
Investigation Device: EZVent Ventilator System is designed for respiratory support in hospitalized mechanical ventilated patients. The Ventilator is designed to be used for adults patients. It is designed to be a stationary product suitable for service in hospitals, critical care situations to provide continuous positive pressure respiratory support to the patient. The ventilator met EDA, ISO 80601-2-12 requirements on essential performance of critical care ventilator and other applicable international standards.
Study Title: Open-labeled, non-randomized, self-controlled study to evaluate the safety and performance of EZVent in hospitalized mechanically ventilated patients. Investigational Device EZVent Ventilator System.
Purpose: Evaluation of the safety and performance of EZVent in hospitalized mechanically ventilated patients.
Objectives: Evaluation of the safety and performance of EZVent through monitoring the vital signs and arterial blood gases (ABG) in comparison to a commercial ventilator.
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
- •Male or Female, aged 18 years or above.
- •Mechanically ventilated Patients (on either VC, PC or CPAP modes).
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Considered clinically stable, with FiO2 less than 60% and PEEP no greater than 10 cm H2O
排除标准
- •Pregnant Women
- •Patients who experienced myocardial infarction within the last 6 weeks.
- •Shocked patients, Hemodynamic instability requiring vasopressors, cardiac arrhythmias, terminal malignancy.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
结局指标
主要结局
Comparable lung mechanics parameters
时间窗: 0-120 minutes
Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0
Comparable gas exchange parameters
时间窗: 0-120 minutes
Comparable gas exchange parameters (PaCO2) at T2 (120 minutes after the patient was on EZVent) in relation to readings at T0 (Baseline readings when the patient was connected to his/ her original standard traditional mechanical ventilator).
Comparable hemodynamic and vital parameters
时间窗: 0-120 minutes
Comparable hemodynamic and vital parameters (Blood pressure) at T2 when the patient is on EZVent in relation to at T0
次要结局
- Serious adverse events(0-120 minutes)