AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
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
- Ambulatory oximetry/activity profile
研究概览
简要总结
Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. The basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. Accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. The three main objectives of this study are 1) determine the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran patients with a diagnosis of COPD or other chronic lung disease
- •able to read and understand English
- •> 45 years old
- •ambulatory and able to perform functional testing
排除标准
- •unable or unwilling to give informed consent
- •daily use of a motorized cart
- •impairment of cognition or communication
- •history of drug or alcohol treatment within the past 6 months
- •poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable
- •Recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time
结局指标
主要结局
Ambulatory oximetry/activity profile
时间窗: Data is collected over 30-34 consecutive hours
Oxygen saturation is measured with a pulse oximeter that has the capacity to collect data over 30- 34 hours; physical activity is measured with two pizo-electric accelerometers. Oximetry and activity data are synchronized to define a profile of oxygen saturation that is linked to usual daily activity.
次要结局
未报告次要终点
研究者
Miriam D Cohen
Nurse Practitioner
VA New York Harbor Healthcare System