Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- Length of hospital stay in hours since the admission to the emergency room.
研究概览
简要总结
The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age.
FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.
详细描述
This is a controlled, randomized, open-label, multicentre trial. Patients will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the "FreeO2" group for automatic oxygen flow titration or in the "manual" group for Oxygen therapy with manual flow titration. The SpO2 will be recorded continuously in both groups of the study using the FreeO2 device throughout the duration of hospitalization; In the group "FreeO2 ", the device will record the data continuously and allow the automation of oxygen titration - in the group "Manual", the device will only be used to monitor SpO2 and heart rate.
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
盲法说明
The technology used does not allow blinding.
入排标准
- 年龄范围
- 1 Month 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants from 1 month of age and less than 1 year of age who present a first episode of bronchiolitis and require oxygen therapy
- •Informed consent of parents (written informed consent will be obtained from the patients' parents or legally authorized representatives)
- •Affiliation to the French social security system
排除标准
- •Need for oxygen flow higher than 3 L / min to maintain SpO2 greater than 92%
- •Patient with severity criteria according to the 2019 French National Authority for Health (HAS) guidelines and for whom it's indicated to maintain SpO2 above 94%
- •Criteria of severity justifying from the start another technique of assisted ventilation:
- •Polypnea: respiratory rate (FR)> 80 c / min.
- •Consciousness with glasgow score (GSC) <or =
- •Hemodynamic instability (mean arterial pressure (MAP) <- 2 SD for age or use of vasopressors).
- •Cardiac or respiratory arrest.
- •PCO2> 55 mm Hg and pH <7.20 when blood gas are performed
- •Need for urgent surgery
- •Contraindication to the FreeO2 device as described in the user manual
- •Lack of informed consent from parents
- •Premature birth with a gestational age at birth under 36 weeks
- •Severe co-morbidities (cystic fibrosis, immune deficiency, congenital heart disease, neuromuscular illness)
结局指标
主要结局
Length of hospital stay in hours since the admission to the emergency room.
时间窗: 30 days max
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.
次要结局
- Number of patients readmited to hospital within 7 days and 30 days following discharge(30 days max)
- Duration of enteral feeding (hours)(30 days max)
- Duration of intravenous hydration (hours)(30 days max)
- Number of patient admitted to the intensive care unit within 3 days following the hospital admission(30 days max)
- Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)(30 days max)
- Number of patients needing assisted ventilation (invasive or noninvasive )(30 days max)
- Number of reported Adverse Events(30 days max)
- Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).(30 days max)