Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 386
- 试验地点
- 2
- 主要终点
- Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide.
Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated.
Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
详细描述
Patients admitted for a severe exacerbation of COPD that required NIV or invasive ventilation or high flow therapy will be screened for the trial once they reach clinical stability that allow weaning of NIV, invasive ventilation, or high flow therapy.
The screening visit will take place during a standard consultation between 2 days following admission for acute hypercapnic respiratory failure and no later than 30 days following the discharge from the acute ward.
The inclusion visit will be performed no later than 30-days following discharge from the acute ward.
Follow-up visits will be performed at 3, 6 months after inclusion with a +/-14 days window.
Visits will be conducted in the hospital unless patient is unable to attend due to medical condition or healthcare crisis (infectious pandemic for example). In that case, a remote consultation will be performed to retrieve data available without physical attendance.
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
- Single (Participant)
盲法说明
Clinical experts in charge of assessing whether a hospitalization was caused by a COPD exacerbation will blinded to the assigned treatment.
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and < 85 years
- •Patient with a diagnosis of COPD according to GOLD guidelines
- •Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH <7.35 with PaCO2 >45mmHg/6kPa)
- •Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
- •Patient with an overnight polygraphy or polysomnography performed 2 to 30 days following weaning from acute NIV or invasive ventilation showing an obstructive apneahypopnea index >=15/h. For patients already diagnosed with OSA, results from their prior sleep study will be retrieved. If not accessible, overnight polygraphy or polysomnography will be repeated.
- •Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
- •Patient who has read and understood the information letter and signed the consent form
排除标准
- •Patient with NIV treatment
- •Patients who decline any use of NIV or CPAP in the home setting
- •Significant psychiatric disorder or dementia that would prevent adherence to study protocol
- •Tobacco use <10 pack-year
- •Expected survival <12 months due to any condition other than COPD.
- •Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- •Pregnant or breastfeeding women
- •Patient already involved in an interventional research protocol that would impact the outcome measured in the current protocol.
研究组 & 干预措施
Non-invasive Ventilation (NIV)
Patients randomised to the intervention arm will be established on NIV before discharge to home.
干预措施: Non-invasive Ventilation (NIV) (Device)
Continuous Positive Airway Pressure (CPAP)
Patients randomised to the control arm will be established on CPAP before discharge to home.
干预措施: Continous Positive Airway Pressure (CPAP) (Device)
结局指标
主要结局
Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.
时间窗: 0-12 months from inclusion
Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.
Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.
时间窗: 0-12 months from inclusion
Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.
次要结局
- Quality of life of NIV over CPAP(At month 12)
- Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index).(From Day 1 to Day 90)
- Benefit of compliance and tolerance of NIV over CPAP(From Day 1 to Day 365)
- Benefit of NIV over CPAP regarding usefulness of CPAP/NIV data to predict COPD severe acute exacerbation.(At month 12)
- Evaluate the benefit of NIV over CPAP regarding control of sleep disordered breathing(0-12 months from inclusion)
- Quality of sleep of NIV over CPAP (Insomnia Severity Index).(From Day 1 to Day 365)
- Respiratory function benefit of NIV over CPAP(At month 12)
- Exercise capacity benefit of NIV over CPAP(At month 12)
- Quality of sleep of NIV over CPAP in centres that will perform overnight polysomnography(From Day 1 to Day 365)
- Quality of life of NIV over CPAP(At month 12)
- Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index).(From Day 1 to Day 90)
- Quality of sleep of NIV over CPAP (Insomnia Severity Index).(From Day 1 to Day 365)
- Quality of sleep of NIV over CPAP in centres that will perform overnight polysomnography(From Day 1 to Day 365)
- Respiratory function benefit of NIV over CPAP(At month 12)
- Exercise capacity benefit of NIV over CPAP(At month 12)
- Benefit of compliance and tolerance of NIV over CPAP(From Day 1 to Day 365)
- Benefit of NIV over CPAP regarding usefulness of CPAP/NIV data to predict COPD severe acute exacerbation.(At month 12)
- Quality of sleep of NIV over CPAP(From Day 1 to Day 365)