Implementation of a Precision Sleep Ventilation (PSV) Chronic Respiratory Failure Management Program for Patients With Advanced Hypercapnic COPD
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to readmission or death
研究概览
简要总结
Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.
The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.
详细描述
The purpose of this protocol is to perform a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure. The study will focus on the primary end-points of time to hospital re-admission for acute exacerbation of COPD and/or an episode of acute on chronic hypercapnic respiratory failure, in addition to other clinically relevant outcomes including patient health-related quality of life, sleep quality indices, and gas exchange parameters. Approximately 300 BIDMC adult patients will be recruited and each patient monitored over a period of 12 months.
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
- •Signed informed consent prior to any study-mandated procedure.
- •Male or female aged ≥ 18 years with advanced hypercapnic COPD
- •FEV1 ≤ 50% predicted and
- •Prolonged hypercapnia during the daytime, at rest, without O2 or ventilatory support, PaCO2 > 52 mmHg on ABG (performed off of NIPPV), compensated with pH > 7.30
- •Willingness to use NIPPV treatment
- •English speaking
- •Women and minorities will be recruited in numbers reflecting representation in the Boston Metropolitan community which is approximately 84% Caucasian, 9% African American, 5% Hispanic American, and 2% Asian American, as the knowledge gained can apply to individuals of all ethnic background and gender.
- •We do not wish to limit our sample to a highly selected group of patients, to allow for more generalizable results.
排除标准
- •Subjects will be excluded from participation in the study for a history of:
- •Significant sleep disordered breathing (AHI 4% ≥ 15 events/hour) or high clinical suspicion (BMI ≥ 35)
- •Neuromuscular disease or other causes of hypoventilation
- •Abnormalities of the thorax or lungs other than COPD
- •Already treated with home NIPPV
- •Unable to wean from ventilator during admission
- •Unable to wean from NIPPV, pH < 7.30
- •Recent tracheotomy decannulation
- •History of severe depression or bipolar disorder requiring prior hospitalization or suicide attempts or ideation
- •Cognitive impairment (such as advanced dementia) that would limit ability to provide consent or to use NIPPV
- •Active recreational drug use
- •Unstable housing that would limit ability to use NIPPV
- •Severe heart failure (New York Heart Association stage IV)
- •Active/unstable CAD
结局指标
主要结局
Time to readmission or death
时间窗: within 12 months
time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death
次要结局
- Patient health related quality of life (HRQOL)(12 months)
- Dyspnea scale(12 months)
- Gas exchange(12 months)
- General health status(12 months)