Open Label, Non-randomised, 1-day Trial to Characterize the Performance of Two Adapter Devices Designed to Permit Use of the Respimat® Inhaler Device With Patients Requiring Mechanical Ventilation.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Pre-dose Subtracted Maximum Measured Concentration of Ipratropium
研究概览
简要总结
The general aim of this 1-day, open label, non-randomised, trial is to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler with patients requiring mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combivent Respimat via tee adapter
Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter
干预措施: Combivent Respimat via tee adapter (Drug)
Combivent Respimat - ventilator adapter
Patients (all); previously intubated and ventilated; in need of bronchodilation with /CVT-R via ventilator adapter
干预措施: Combivent Respimat via ventilator adapter (Drug)
结局指标
主要结局
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium
时间窗: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication
Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium. Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint.
Pre-dose Subtracted Maximum Measured Concentration of Albuterol
时间窗: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication
Pre-dose subtracted maximum measured concentration (Cmax) of albuterol. Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint.
次要结局
- Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol(Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication)