NCT03368612Unknown不适用
Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function
Ospedale Santa Croce-Carle Cuneo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年9月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- respiratory rate
研究概览
简要总结
The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.
详细描述
Primary endpoint:
• To test the AirGoTM system's respiratory rate recording accuracy at rest and during physical exercise, as compared to standard tests.
Secondary endpoints:
- To test the accuracy of the AirGoTM system's derived respiratory parameters (tidal volume, minute ventilation, Tiffeneau-Pinelli index, FEV1 and VO2max) at rest and during physical exercise, as compared to standard tests.
- To test comfort and subjects' compliance with the AirGoTM system during long term recording (24 hours).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Non-smoker healthy volunteers,
- •Able to perform a routine respiratory function test (spirometry and cardiopulmonary exercise testing),
- •aged between 18 and 75 years,
- •who signed a written informed consent.
排除标准
- •Present cardiac comorbidities (eg. coronary artery disease, heart failure, arrhythmias);
- •History of coronary artery disease or heart failure;
- •Respiratory comorbidities (eg. asthma, chronic obstructive disease, sleep apnoea, lung interstitial disease);
- •Pregnancy;
- •Former smoker of >5 p/y;
- •Severe trauma or major surgery in the last year;
- •Chest pain;
- •Obesity (BMI >30).
结局指标
主要结局
respiratory rate
时间窗: 4 minutes
number of respiratory cycles completed in one minute
次要结局
- tidal volume(4 minutes)
研究者
Andrea Antonelli
Principal Investigator, MD
Ospedale Santa Croce-Carle Cuneo
研究点 (1)
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