Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Dyspnoea
研究概览
简要总结
The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and 90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.
Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide, Heliox 28 and oxygen.
Conventional oxygen supplementation is often used in these patients, but it may be inadequate, especially if they require high flows (from 30L/min to 120L/min in acute respiratory failure).
High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which generates the gas flow rate up to 55 L/min and a heated humidification system. This technology may have an important role in reducing respiratory distress in do-not-intubate patients.
Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration; a better matching between patient's inspiratory demand and oxygen flow; generation of a certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure and recruitment; improvement of lung and airway mucociliary clearance due to the heated and humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and speech.
The investigators hypothesize that patients supported with HFONC need less opioids to decrease dyspnoea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis, COPD, ...) - (McCabe score > 3 [<6 months life expectancy] and a Palliative Prognostic Index score ≥ 4) admitted to hospital because of acute respiratory failure and distress
- •Had chosen to forego all life support and receiving only palliative care
- •Severe hypoxemia (PaO2/FiO2< 250)
- •At least one of the following: dyspnoea (Borg scale ≥4), signs of respiratory distress, and respiratory rate greater than 30 beats per min
排除标准
- •Patients had to be competent (Kelly score <4)
- •Refusal of treatment
- •Weak cough reflex
- •Agitation or non-cooperation
- •Uncontrolled cardiac ischemia or arrhythmias
- •Failure of more than two organs
- •Use of opioids within the past 2 weeks
- •Adverse reactions to opioids
- •History of substance misuse
- •Known contraindication for morphine (acute renal failure and recent head injury)
结局指标
主要结局
Dyspnoea
时间窗: 2 days
We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
Opioids
时间窗: 2 days
By randomizing the two groups we will be able to compare the total use of opioids.
次要结局
- Patient comfort(2 days)
- Mortality(6 months)
- Physiologic variables(2 days)
研究者
Miguel R. Goncalves
Clinical Professor, PH.D
Hospital Sao Joao