NCT05196698招募中不适用
Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2022年8月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
研究概览
简要总结
The objective of the study is to evaluate the efficacy of home High Flow Oxygen for the reduction of severe exacerbation following admission for a severe exacerbation of COPD or death against standard oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a diagnosis of COPD defined by GOLD guidelines
- •Admitted in hospital for AECOPD
- •With severe respiratory impairment defined by one of the following criteria (long-term oxygen therapy (LTOT) criteria):
- •Previously established on long-term oxygen therapy according to the following criteria: PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heart failure on room air in stable condition Or
- •PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heart failure on room air after clinical stabilization during the index admission
- •Patients affiliated or, beneficiary of a social security cover
- •Patient who has read and understood the information letter and signed the consent form
- •For woman of childbearing potential, use of an effective contraception (oestro-progestatives or intra-uterine device or tubal ligation) since at least 1 month and an blood pregnancy test by β-HCG negative at the screening visit, during the duration of the study
- •For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)
排除标准
- •Age <18 or > 85 years
- •Patient treated with chronic NIV with ongoing treatment
- •Patients diagnosed with obstructive sleep apnea (OSA) treated with CPAP. Diagnosis of OSA will be over-ruled in patient that had a previous overnight polygraphy. For patients who never had an overnight polygraphy, screening for OSA will be made using the STOP-BANG questionnaire. If the results of the STOP-BANG questionnaire (Appendix 1) is >3, an Apnea-link recording will be performed. If AHI>30/h, patient will be excluded.
- •BMI > 35 kg/m2
- •Patient admitted for an acute COVID-19 infection
- •Hypercapnic respiratory failure justifying NIV defined as
- •An Arterial Blood Gas (ABG) PaCO2 > 7 kPa in stable condition within 6 months
- •Patients with ABG PaCO2 > 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge
- •Pregnancy (blood pregnancy test positive) or lactation ongoing
- •Significant psychiatric disorder or dementia that would prevent adherence to study protocol
- •Tobacco use < 10 pack-year
- •Expected survival < 12 months due to any situation other than COPD disease
- •Refusal of high-flow oxygen therapy
- •Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- •Patients already involved in a research protocol that would impact with the outcome measured in the current protocol
研究组 & 干预措施
High Flow Oxygen Therapy
Experimental
干预措施: High Flow Oxygen Therapy (Other)
Long-Term Oxygen Therapy
Other
Control arm
干预措施: Long-term oxygen therapy (Other)
结局指标
主要结局
time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
时间窗: 12 months
time to death
时间窗: 12 months
次要结局
- Number of Adverse events(12 months)
- Change from Baseline in Health-related Quality of Life(12 months)
- Change from Baseline in Health-related Quality of Life(3 months)
- Change from Baseline in Health-related Quality of Life(6 months)
- Number of Adverse events(3 months)
- Number of Adverse events(6 months)
研究者
研究点 (1)
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