Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Primary performance criterion is the overall estimated duration of oxygen use
研究概览
简要总结
The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy.
详细描述
Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients with severe lung disease. This continuous or sub-continuous oxygen supplementation is generally introduced at home in patients who have chronic cardio respiratory failure and severe resting hypoxemia to maintain sufficient blood oxygenation and therefore preserve vital organ function.
LTOT effectiveness has mainly been evaluated and documented in patients with COPD, which also accounts for most of its prescriptions. In these patients, LTOT has been shown to have a beneficial impact on haemodynamics, exercise capacity, lung mechanics and mental state. Its implementation was furthermore associated with reduced yearly hospitalisation days and increased survival Measuring adherence is an extremely important and under-evaluated component of oxygen therapy. NOWOX, medical device has been designed,developed and manufactured to measure adherence to LTOT and additionally to measure patient's respiration rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged ≥ 18 years and ≤ 75 years,
- •Having a documented diagnosis of moderately severe to severe chronic obstructive respiratory disease
- •Hospitalised or out-patient requiring transient or long term oxygen therapy,
- •Able to be weaned from oxygen for several consecutive minutes (around 30 minutes, SpO2 at rest on room air should not drop < 85%),
- •Able to read
- •Willing and able to complete the requirements of this study including providing his/her signature for the written informed consent.
排除标准
- •Clinically unstable patient,
- •Any contraindication to perform a light cycling exercise, according to the 2003 ATS/ACCP guidelines
- •Tracheostomy,
- •Nasal obstruction or acute rhinitis occurring in the week prior to selection,
- •For female patient:
- •Pregnant,
- •Positive urinary pregnancy test
- •Lactating mother or lack of efficient contraception
- •Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
- •Known allergic reactions to medical material compounds used in the study
- •Drug abuse or psychic disorders
- •Legal status which prohibits informed consent,
- •Participation in any interventional clinical trial within 30 days prior to selection.
结局指标
主要结局
Primary performance criterion is the overall estimated duration of oxygen use
时间窗: 6 hours
次要结局
- secondary performance criterion: instantaneous respiration rate recorded by the NOWOX(6 hours)
- secondary performance criterion: patient's satisfaction questionnaire on the NOWOX(1 hour)