Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Diagnostic accurarcy measures of structured self-monitoring
研究概览
简要总结
This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel.
详细描述
This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period, participants will perform SSM. They are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness.
A planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnostic accurarcy measures of structured self-monitoring
时间窗: Day 1 to 3 at 3100m
Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the the curve. The diagnostic performance will be compared statistically using c-statistics against the reference test. Reference test will be the occurence of altitude-related illness defined as the following: * AMS defined by the Lake Louise questionnaire score or with AMSc score * severe hypoxemia (SpO2 \<80% at rest \>30 min; or SpO2 \<75% at rest \>15 min; * intercurrent illness that cannot be relieved by simple measures such as paracetamol 3x500 mg/day, inhalation of bronchodilators. * dyspnea or discomfort at rest requiring treatment with oxygen * chest pain or ECG signs of cardiac ischemia * severe hypertension: systolic blood pressure \>200 mmHg, diastolic blood pressure \>110 mmHg * new onset neurologic impairment * Any condition that requires study withdrawal according to the decision of the independent physician
次要结局
- Changes in ST-Segment of the ECG during ergometry(Day 1 at 760 and 3100m)
- Spirometric measurement of forced expiratory volume in one second(Day 2 at 760 and 3100m)
- Six-minute walk distance in meters(Day 2 at 760 and 3100m)
- Arterial partial pressure of oxygen(Day 2 at 760 and 3100m)
- Altitude-related illness, incidence(Day 1 to 3 at 3100m)
- Acute mountain sickness severity assessed by the Lake Louise score(Day 1 to 3 at 3100m)