Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 4
- 主要终点
- Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
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 in the emergency department in a patient population admitted for acute respiratory failure.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Admission to the emergency for respiratory disease (or cardiac - acute pulmonary edema)justifying an oxygen administration to over 3 L / min to maintain a SpO2 ≥ 92%.
- •Inclusion within a time less than two hours after the start of the oxygen at the emergency.
- •Patient consent,or a close.
排除标准
- •Necessity of an oxygen flow exceeds 15 L / min to maintain a SpO2 higher than 92%.
- •Criteria of gravity justifying immediately a different technique of ventilatory support:
- •Disturbance of consciousness with a Glasgow Coma Score ≤ 12
- •Serious ventricular rhythm disorders
- •Hemodynamic instability (SBP <80mmHg or recourse to vasopressors)
- •Cardiac or respiratory arrest
- •pH < 7.35 and PaCO2 > 55 mm Hg
- •Necessity of a urgent surgery, or coronary revascularization
- •Age <18 years
- •Pregnant women, lactating
- •Patient not relevant
- •Unavailability of the prototype FreeO2
研究组 & 干预措施
device FreeO2
Automatic adjustment of oxygen
干预措施: Device FreeO2 v2.0 (Device)
Manual oxygenation
Manual adjustment of oxygen
干预措施: Device FreeO2 v2.0 (Device)
结局指标
主要结局
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
时间窗: 3 hours or 1 hour after after cessation of oxygenation
The target zone of oxygen saturation is : SpO2 = 92-96% The "acute phase of treatment" is defined by the 3 first hours of treatment by oxygenation and/or until one hour after the end of this last.
次要结局
- Frequency of use of invasive or noninvasive ventilation during hospitalization.(28 days max)
- nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures(3 days max)
- Maintaining EtCO2 in a selected area(3 hours or 1 hour after after cessation of oxygenation)
- Oxygen consumption measured at the end of administration(3 hours or 1 hour after after cessation of oxygenation)
- Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).(3 hours or 1 hour after after cessation of oxygenation)
- Duration of administration during hospitalization(28 days max)
- Number of complications related to the administration of oxygen(28 days max)