A Dose Finding Study to Determine the Optimal Flow Rate and Oxygen Concentration Using High Flow Nasal Oxygenation for Patients With Respiratory Failure.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Median FiO2 (%) needed to be delivered via high flow therapy (Optiflow), at 3 different flow rates, to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in 3 groups of patients with acute respiratory failure
研究概览
简要总结
High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately high oxygen concentration should be avoided as there is increasing evidence that the production of oxygen free radicals can lead to lung damage. This pilot dose finding study will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with respiratory failure requiring low, medium or high oxygen concentration from conventional low flow devices. An assessment will also be made of comfort and compliance with HFNO2.
详细描述
The study will recruit a total of between 180 and 270 patients across three hospital sites mainly from high dependence units.
The patients recruited will be stratified into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high).
All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.
End points:
Minimal FiO2 required to maintain saturation above 94% for patients with low, medium and high recruitment oxygen requirements for 30 litres, 45 litres and 60 litres per minute. Use Kruskal Wallis to compare the median FiO2 requirements of those patients who recruited with low, medium and high O2 requirement.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18-80 at time of recruitment to study) Able to give their own consent (4 "A" Test score of 0 if capacity questionable) Acute respiratory failure but no significant deterioration in the previous hour Receiving conventional oxygen therapy (Hudson, Venturi, non-rebreathing mask or equivalent) up to a maximum of 90% Oxygen saturation ≥ 94% and respiratory rate ≤30
排除标准
- •Type II respiratory failure (chloride ≤95 and bicarbonate ≥35, on an arterial blood gas or venous sample within 4 weeks) Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V) Pregnancy Heart failure (NYHA Grade III or IV) Decreased GCS Cardiovascular instability (systolic BP ≤90 or heart rate ≥130) Pulmonary embolism Unable to give informed consent Contraindication to receiving high flow nasal oxygen
- •Nasal obstruction
- •Previous bleomycin administration
- •Base of skull fracture
研究组 & 干预措施
30 litres per minute
High flow nasal oxygen delivery device 'Optiflow'
干预措施: 'Optiflow' (Device)
45 litres per minute
High flow nasal oxygen delivery device 'Optiflow'
干预措施: 'Optiflow' (Device)
60 litres per minute
High flow nasal oxygen delivery device 'Optiflow'
干预措施: 'Optiflow' (Device)
结局指标
主要结局
Median FiO2 (%) needed to be delivered via high flow therapy (Optiflow), at 3 different flow rates, to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in 3 groups of patients with acute respiratory failure
时间窗: 75 minutes after start of study
The median fraction inspired concentration ( FiO2) required to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in patients with respiratory failure using 'Optiflow' device at three different oxygen flow rates 30 litres 45 litres and 60 litres per minute flow within the three stratified groups of low, median and high oxygen requirements (at recruitment to the study).
次要结局
- Number of patients unable to tolerate 'Optiflow' device(0 to 75 minutes after start of study)
- Patient satisfaction scores(75 minutes after start of study)