International Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator and the iFLow Sensor During Routine Use in the Neonatal, Pediatric, and Adult Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP)
研究概览
简要总结
This prospective post market clinical follow up (PMCF) study will evaluate the safety and performance of bellavista ventilator and the iFlow sensors in daily clinical routine.
详细描述
A prospective, multicenter, single-cohort post market observational study, which will analyze data from neonatal, pediatric and adult patients, who are ventilated with the bellavista ventilator.
Ventilator data are continuously recorded in the bellavista ventilator. Patient related data will be recorded in an electronic case report form (CRF). Data from the ventilator and the eCRF are then combined and the primary and secondary endpoints calculated.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ventilated with bellavista
- •Patient in ICU setting
- •Signed informed consent per ethical committee requirements
排除标准
- •Patients expected to be ventilated less than 12 hours
- •The clinical care team does not agree with inclusion of the patient to the study
结局指标
主要结局
Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP)
时间窗: through study completion, an average of 12 hours- 24 days
Difference between set and observed CPAP
Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP)
时间窗: through study completion, an average of 12 hours- 24 days
Difference between set and observed PEEP
Ventilator Performance - Relationship between the set and observed Peak Inspiratory Pressure (PIP)
时间窗: through study completion, an average of 12 hours- 24 days
Difference between set and observed PIP
Ventilator Performance - Relationship between the set and observed tidal volume
时间窗: through study completion, an average of 12 hours- 24 days
Difference between set and observed tidal volume
Ventilator Performance - Relationship between the set and observed flow rate
时间窗: through study completion, an average of 12 hours- 24 days
Difference between set and observed flow rate
次要结局
- Analysis of patient-ventilator interactions - Reintubation rate(through study completion, an average of 12 hours- 24 days)
- Ventilator Safety - Number of study participants with device related adverse events(through study completion, an average of 12 hours- 24 days)
- Failure of noninvasive treatment(through study completion, an average of 12 hours- 24 days)
- Analysis of patient-ventilator interactions - Sepsis(through study completion, an average of 12 hours- 24 days)
- Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia(through study completion, an average of 12 hours- 24 days)
- Ventilator Safety - Device failure rate(through study completion, an average of 12 hours- 24 days)
- Analysis of patient-ventilator interactions - Duration of mechanical ventilation(through study completion, an average of 12 hours- 24 days)
- Length of ICU stay(through study completion, an average of 12 hours- 24 days)
- Length of hospital stay(through study completion, an average of 12 hours- 24 days)
- Extubation failure(through study completion, an average of 12 hours- 24 days)
- Analysis of patient-ventilator interactions - Necrotizing enterocolitis(through study completion, an average of 12 hours- 24 days)
- Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events(through study completion, an average of 12 hours- 24 days)
- Hospital mortality(through study completion, an average of 12 hours- 24 days)
- Analysis of patient-ventilator interactions - Pneumothorax rate(through study completion, an average of 12 hours- 24 days)
- Analysis of patient-ventilator interactions - Retinopathy of prematurity(through study completion, an average of 12 hours- 24 days)
- Intraventricular hemorrhage(through study completion, an average of 12 hours- 24 days)