Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Clinact
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- admission-free survival
研究概览
简要总结
The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.
详细描述
By 2020, chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death in the world, especially in countries of middle to high income, like EU. Despite the improvements in survival by using acute non- invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of re-admission and further life-threatening events. Furthermore, in a recent study of 110 patients who had AHRF (RESCUE study, Struik, Thorax 2014), at one year after discharge 65% had another life-threatening event, and 49% had died. New recent data suggests that NIV at home can reduce re-admissions (HMV-LTOT, Murphy, JAMA 2017), but in a small proportion of patients, and with a high level of expertise. There is an urgent need to develop strategies to reduce the number and severity of exacerbations of COPD. With healthcare objectives and budget constraints, telemonitoring of COPD patients is an important challenge in most European countries. RESCUE2-Monitor is the next step. This European trial (currently, France, Spain and Portugal) will test the hypothesis that home NIV, with a highly adapted ventilatory strategy (hereafter referred to as 'TARGETED VENTILATION'), compared to no home NIV (only hospital NIV), to non-targeted home NIV or to rescue home NIV will reduce re-admission to hospital or death in COPD patients, is possible using e-medicine, and will reduce costs of health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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
- •1) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65%;
- •2) AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);
- •3) 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).
排除标准
- •Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;
- •Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician;
- •BMI > 35 kg/m2;
- •Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);
- •Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI>30/h (French criteria);
- •Cognitive impairment that would prevent informed consent into the trial
- •Tobacco use < 10 pack-year;
- •Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge;
- •Unstable coronary artery syndrome;
- •Age <18 years;
- •Inability to comply with the protocol;
- •Expected survival<12 months due to any situation other than COPD disease;
- •Duration of ICU stay>10 days;
- •No affiliated to national health insurance;
- •Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.
结局指标
主要结局
admission-free survival
时间窗: 0-36 months
defined as time from randomisation to hospital admission in relation with severe exacerbation of COPD or death from any cause, whichever event occurred first, estimated using the Kaplan-Meier method. If neither event occurs, then time will be taken from day randomisation to the last known follow up visit. If withdrawal occurs prior to death, time will be taken from the day of randomisation to day of withdrawal.
次要结局
- Frequency of exacerbations requiring hospitalization(12 months)
- Frequency of exacerbations resulting in physician directed treatment(12 months)
- Overall survival(0-36 months)
- Assessment of Quality of life with St George's respiratory questionnaire(0,1, 3, 6, 24 and 36 months)
- Assessment of Quality of life with the COPD Assessment Test (CAT)(0,1, 3, 6, 24 and 36 months)
- Adverse events (AEs) frequency(0, 3, 6, 12, 18, 24 and 36 months)
- Assessment of Quality of life with the 5-level EQ-5D version(0,1, 3, 6, 24 and 36 months)
- Assessment of Quality of sleep with Pittsburgh Sleep Quality Index(0,1, 3, 6, 24 and 36 months)
- Assessment of dyspnea with Modified Medical Research Council (mMRC) scale(0,1, 3, 6, 24 and 36 months)
- Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide(0, 1, 3, 6, 12, 18, 24, 30 and 36 months)
- Assessment of Exacerbation based on changes in arterial partial pressure of oxygen(0, 1, 3, 6, 12, 18, 24, 30 and 36 months)
- Assessment of Quality of life with SF-36(0,1, 3, 6, 24 and 36 months)
- Assessment of Quality of life with Severe Respiratory Insufficiency Questionnaire(0,1, 3, 6, 24 and 36 months)
- Assessment of Quality of life with the Charlson Comorbidity Index(0,1, 3, 6, 24 and 36 months)
- Assessment of Quality of sleep with Epworth Sleepiness Scale(0,1, 3, 6, 24 and 36 months)