Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Time to first hospitalization or death from all causes
研究概览
简要总结
This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
详细描述
This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.
The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.
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
- •Age 40 years or older
- •Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
- •COPD or ILD as main underlying reason for LTOT
- •Oxygen concentrator as stationary oxygen source in the home including night-time
- •Body mass index (BMI) < 35 kg/m2
排除标准
- •Current or previous treatment with home HFOT
- •Current treatment with home mechanical ventilation
- •Current treatment with home CPAP
- •Hospitalized during the last 2 weeks
- •Current smoking or contact with flames
- •Self-reported average use of the LTOT < 15h per day (24 hours)
- •PaCO2 (breathing air at rest) > 8 kPa
- •Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
- •Inability to participate in the study procedures (as judged by the staff)
- •Not eligible for continuing LTOT due to other reason (as judged by the staff)
- •Expected survival less than 3 months (as judged by the staff)
研究组 & 干预措施
High-flow oxygen therapy
Intervention arm
干预措施: Added high-flow oxygen therapy (Device)
Low-flow oxygen therapy
Comparison arm
干预措施: Standard care (Other)
结局指标
主要结局
Time to first hospitalization or death from all causes
时间窗: 1 year
Time to first hospitalization or death from all causes during 1 year after randomization in people with COPD (assessed using nationwide registry data)
次要结局
- Time to first all-cause hospitalization or all-cause death(1 year)
- Hospitalization rate from respiratory disease(1 year)
- Number of hospitalized days(1 year)
- Mortality rate from cardiovascular disease(1 year)
- Rate of hospitalizations or death from all causes(1 year)
- Hospitalization rate from cardiovascular disease(1 year)
- Number of admissions to intensive care unit (ICU)(1 year)
- Adverse events(3 and 12 months)
- Health-related quality of life(3 and 12 months)
- Number of days in ICU(1 year)
- Mortality rate from all causes(1 year)
- Mortality rate from respiratory disease(1 year)
- Number of exacerbations(1 year)
- Need for home mechanical ventilation(1 year)
- Primary care utilization(1 year)
- Hospitalization rate from all causes(1 year)
- Time to first exacerbation(1 year)
- Incidence of cardiovascular disease(1 year)
- Health status(3 and 12 months)
- Nasal symptoms(3 and 12 months)
- Rate of withdrawal of long-term oxygen therapy(1 year)
- Breathlessness at exertion(3 and 12 months)
- Breathlessness(3 and 12 months)
- Sleep quality(3 and 12 months)
- Physical activity(3 and 12 months)
- Change in health status(3 and 12 months)
研究者
Magnus Ekström
Associate Professor, Senior Lecturer
Skane University Hospital