Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 13
- 主要终点
- iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
研究概览
简要总结
This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system.
A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.
The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.
详细描述
This study is intended to describe daily practice and therefore, there is not a standardized protocol but only patient-based and site-based questionnaires.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn > or = to 34 weeks gestational age suffering from hypoxic respiratory failure with pulmonary hypertension (France only) or patient presenting post-operative pulmonary hypertension associated with cardiac surgery (France and Belgium) · Patient treated with iNO delivered with EZ-KINOX™
排除标准
- •Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
- •Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
结局指标
主要结局
iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments
时间窗: Through iNO administration, an average of 4 days
Data collected by questionnaire
次要结局
- Number and percentage of patients with adverse events(During iNO administration, an average of 4 days)
- Investigator's opinion regarding EZ-KINOX use(Through iNO administration, an average of 4 days)
- Profile of patients: age, gender, disease characteristics.(1 day)
- Number and percentage of patients with adverse drug reaction(From 1h after the end of iNO administration up to 28 days after ICU discharge)