The Effect of Oxygen Therapy With Airvo High-flow Heated Humidification for Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Reduction in the number of exacerbations and thus hospital admissions, based on data on hospital admissions.
研究概览
简要总结
The purpose of our study is to establish whether domiciliary use of the Airvo warm passover humidifier can reduce the number of exacerbations in patients with respiratory insufficiency. Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in long term oxygen therapy (LTOT). The following questions will be investigated:
Do outpatients receiving long term oxygen therapy benefit if this is delivered through an Airvo humidification system. The proposed benefits under investigation are:
- a reduction in the number of exacerbations and thus hospital admissions?
- an increase in quality of life (QOL)?
- an improved lung function and thus increased physical activity?
详细描述
Experience at Aalborg University Hospital's Department of Pulmonary Medicine (Lungemedicinsk Afdeling) in Denmark gives rise to a renewed interest in the investigation of the properties and effects of humidification in COPD patients in LTOT. For the last 5 years, the department has discharged fibrosis patients with oxygen flow > 6 l/min with a warm mist humidifier. The initiative has given clear indication that infection ratios can be reduced and the QOL increased. Many COPD patients experience improved oxygen saturation when oxygen treatment for respiration insufficiency is given with warm humidification.
Previous studies have typically concerned other patient categories and involved the use of cold-water humidifiers. To increase air moistening, the temperature must be raised as moisture absorption capability increases with temperature. The 2009 study of Rea et al. (9) examined the effect of warm humidification on COPD and bronchiectasis patients, who used a warm humidifier (MR 880) on average for two hours per day. LTOT was not an inclusion criterion in the study, and the severity of COPD varied. Despite the relatively short time of use the study demonstrated the beneficial effect of humidification on exacerbation frequency.
Our study therefore aims to examine the effect of using warm humidification as a minimum during the night - preferably for 8 hours.
In addition to their usual oxygen apparatuses, the treatment group will have an Airvo warm humidifier installed in the home. Their respiratory gas flow setting will be increased to 20-25 l/min based on patient preference; then the peripheral saturation readings will form the basis for adjusting the oxygen flow rate.
The control group will continue receiving the standard oxygen therapy prescribed by the department.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have severe/very severe COPD diagnosis
- •have had chronic respiratory insufficiency for at least 3 months and be in steady oxygen therapy (LTOT) with a minimal supplement of 1 litre of oxygen per minute for at least 16 hours per day
- •understand and accept oral and written information in Danish
- •be capable of handling the Airvo warm humidifier after instruction.
排除标准
- •Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness)
- •Bronchiectasis without simultaneous COPD diagnosis
- •Treatment with BiPAP in the home
- •Affected level of consciousness
- •Smoking status change during project period.
研究组 & 干预措施
High Flow humidification system
In addition to their usual oxygen apparatuses, the treatment group will have an Airvo humidifier system installed in the home. The supplied oxygen flow will be entrained along with room air through the Airvo humidification system. this combined respiratory gas will then be warmed and humidified and delivered to the patient via a nasal cannula. The total respiratory gas flow rate will be between 20-25 l/min, depending on participant´s preference. Then the oxygen fraction is adjusted until the subjects target oxygen saturation levels are achieved.
干预措施: Airvo humidifier (Device)
Standard oxygen therapy
The control group will continue receiving the standard oxygen therapy prescribed by the department
结局指标
主要结局
Reduction in the number of exacerbations and thus hospital admissions, based on data on hospital admissions.
时间窗: one year
Outcomes relating to exacerbations will be recorded according to GOLD COPD guidelines: An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD (3). At inclusion of the patient, the number of exacerbations (deterioration) in the last year, based on data on the need for antibiotics and/or prednisolone (corticosteroid), and hospital admissions will be registered. Data will be recorded via extracts from AS400 and the prescription database. To ensure data validity concerning redeemed prescriptions, patients will be asked about the number of self-treatment plans. At project completion, the same metrics are recorded for the entire period.
次要结局
- improved lung function, using Spida 5 equipment.(one year)
- increase in quality of life, measured by St George's Respiratory Questionnaire (SGRQ),(six month and one year)
- Improved physical ability, based on six-minute walk test.(one year)
研究者
Birgitte Schantz Laursen
Associated professor
Aalborg University Hospital