Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Possibility to use a new closed-loop system for oxygen delivery in common practice
研究概览
简要总结
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen and to enable a remote medical monitoring with a homogeneous patient population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.
Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel and to improve the support with centralized monitoring in the FreeO2 group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient hospitalized for COPD exacerbation
- •40 Years and older
- •Former or current smoker greater than or equal to 10 pack-years
- •Suspicion or diagnosis of COPD at the hospitalisation
- •Acute dyspnea or acute aggravation of dyspnea
- •Respiratory rate greater than or equal to 20 breaths/min
- •Patient needs an oxygen therapy by nasal cannula with oxygen delivered between 0.5 to 8L/min to hold SpO2 greater than or equal to 92%
排除标准
- •Imminent indications for intubation
- •FreeO2 system is unavailable at the moment of randomization
- •Patient in isolation (barrier nursing) to the inclusion
- •Patient participates to another clinical trial without possibility of co-enrollment
- •Patient with diagnosis of sleep apnea
研究组 & 干预措施
FreeO2 system
FreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in closed-loop based on the SpO2 signal. This system is intended to maintain SpO2 in a predefined target and to adapt oxygen flow to patient's needs.
干预措施: Automated settings on the oxygen delivery device (Device)
Rotameter (flowmeter)
A rotameter is a device that measures the flow rate of liquid or gas in a closed tube.
干预措施: Manual settings with FreeO2 system in collection mode (Device)
结局指标
主要结局
Possibility to use a new closed-loop system for oxygen delivery in common practice
时间窗: 6 months
We will see if nurses and medical personnel are agree to work with FreeO2 system. We want to know if the new system of automated adjustment of oxygen flow is useful in common practice.
次要结局
- Percentage of time with desaturation during the oxygentherapy(6 months)
- Percentage of time with hyperoxia during the oxygentherapy(6 months)
- Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.(6 months)