Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 406
- 试验地点
- 14
- 主要终点
- Use of intubation within 28 days of randomization
研究概览
简要总结
The goal of this clinical trial is to validate the interest of a strategy adjusting the flow rate delivered under high-flow oxygen (HFO) therapy according to the lung volumes measured by a new technique, in intensive care patients with hypoxemic respiratory distress (HRD).
The main question it aims to answer is:
"The use of a technique of measurement of lung pulmonary with adjustement to the flow rate can make it possible to limite intubation in patients with HRD in intensive care?" The participants will be the patients admitted in intensive care for HRD with the need for treatment with HFO.
This participants will be randomized in :
- the arm control: treated by high flow oxygen therapy according to standard procedures.
- or in the experimental arm : treated by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements, obtained by the depth camera.
详细描述
High-flow oxygen therapy (HFO) is a common technique for the management of patient with hypoxemic respiratory distress in intensive care.The variations in lung volumes induced by the HFO in patients is unknown in clinical routine, in the absence of the availability of a effective measurement technique.
The investigators research team validated a new non-invasive, non-contact technique for measuring lung volumes using depth camera. Using a stereoscopic camera, the patient's chest and abdomen are recognized by a artificial intelligence algorithms. The structures of interest of the chest and the abdomen are the identified and the variation in depth of these points in space allows both the integration of lung volume through automatic calibration procedures, the measurement of respiratory rate and comparaison of movement symetries.
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
- •Patients with hypoxemic respiratory distress define by the following 4 criteria:
- •Respiratory rate ≥ 25 breaths per minutes
- •A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 ≤ 300 mmHg while the patient is breathing oxygen at a flow rate of 10 liters per minutes or more
- •A partial pressure of arterial carbon dioxide (PaCO2) not higher than 45 mmHg
- •An absence of clinical history of underlying chronic respiratory failure
排除标准
- •A do-not-intubate order
- •Pregnant or lactating woman
- •Cardiogenic pulmonary edema
- •Exacerbation of asthma
- •Hemodynamic instability with use of vasopressor at significant dose (norepinephrine > 0.5 mg/h)
- •A Glasgow Coma Scale of 12 points of less
- •Contraindications to non-invasive ventilation
- •Urgent need for endotracheal intubation
- •High flow oxygen therapy started within 48 hours before inclusion
- •Patient under legal protection or deprived of liberty
研究组 & 干预措施
interventional
The interventional arm will consist of patients with hypoxemic respiratory distress treted by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements.
干预措施: high flow oxygen therapy rate adjusted of lung volumes measured (Drug)
Control
The control arm will consist of patients with hypoxemic respiratory distress treated by high flow oxygen therapy according to standard procedures.
结局指标
主要结局
Use of intubation within 28 days of randomization
时间窗: from patient randomization to day 90
Collection of the use of intubation (Yes/No) in patients
次要结局
- Evaluation of respiratory therapy(up to 28 days after randomization)
- Evaluation of organ dysfunction(up to 28 days after randomization)
- Mortality(90 days after inclusion)
- Assessment of patient comfort under high oxygen flow(up to 28 days after randomization)
- Reduced need for ventilatory techniques(from inclusion to day 28)
- Collection of data on clinicians' acceptance of the technique and on ergonomics(from patient inclusion to day 90)