Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease: A Non-randomised Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Control of Nocturnal Hypoventilation
研究概览
简要总结
COPD continues to be a cause of major morbidity for patients. Those patients who also have respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and death and have worse health related quality of life than similar COPD patients without respiratory failure.
Treatment options in this group of patients have been limited and data to support the use of machines to assist breathing (non-invasive ventilators) in stable patients are limited. A major limitation of these devices has been patient acceptance and achieving sufficient control of sleep breathing disturbance.
Currently devices are set at a fixed pressure to support the breathing throughout the night. The new software within the trial device will aim to better match the support provided by the machine to that needed by the patient. It is hoped that this may offer enhanced comfort as well as superior control of respiratory failure.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide.
Treatment options for COPD patients consist of medications, such as bronchodilators and anti-inflammatory drugs, pulmonary rehabilitation, long term oxygen therapy (LTOT), lung volume reduction surgery and lung transplantation. Studies have shown that bronchodilators and anti-inflammatory drugs show minor or no benefit on long term outcomes but rather are used mainly for symptomatic relief.1 Pulmonary rehabilitation has been demonstrated to improve functional status and symptoms but there is lacking evidence on long term outcomes of this therapy. 2 Lung volume reduction surgery and lung transplantation is only appropriate for a small number of patients; therefore, there is no demonstration of improved long-term survival rate.3, 4
Of these available therapies, few have been shown to significantly improve long term patient outcomes. For the severe COPD patient, LTOT is the only treatment that demonstrated prolonged survival in controlled studies. 5, 6 But, despite the effectiveness of LTOT, COPD is still characterized by a high morbidity and mortality rate.
Although the treatment of OSA with CPAP therapy has been associated with reduced hospital admissions and exacerbations there are possible adverse consequences on pulmonary mechanics due to exacerbating hyperinflation.
Noninvasive positive pressure ventilation (NPPV) is one therapy that may prove beneficial to stable COPD patients. NPPV is the use of positive pressure ventilation administered via a nasal or full face mask (that covers both the nose and mouth). This type of ventilation has become a well established and increasingly used therapeutic option for patients with hypercapnic respiratory failure (HRF) due to COPD.7
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
- •Currently using Bilevel device for COPD-OSA overlap syndrome
- •Ability to provide consent
- •Documentation of medical stability by PI
排除标准
- •Subjects, who are acutely ill, medically complicated or who are medically unstable.
- •Subjects in whom PAP therapy is otherwise medically contraindicated.
- •Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- •Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).
研究组 & 干预措施
Intervention
AVAPS-AE
干预措施: AVAPS-AE (Device)
Usual care
Non-invasive ventilation
干预措施: Usual care (Device)
结局指标
主要结局
Control of Nocturnal Hypoventilation
时间窗: baseline, 6 week assessment
transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device
次要结局
- Control of Nocturnal Hypoventilation(2 weeks)
- Exercise Capacity(6 weeks)
- Health Related Quality of Life(6 weeks)
- Total Sleep Time(baseline, 6 weeks)
- Exacerbation Frequency(6 weeks)
- Health Related Quality of Life(2 weeks)
研究者
Patrick Murphy
Clinical Research Fellow
Guy's and St Thomas' NHS Foundation Trust
