Early Signs of Altitude Illness in Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude
- Registration Number
- NCT03957759
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COPD patients Structured self-monitoring during an altitude ascent and stay at high altitude -
- Primary Outcome Measures
Name Time Method Diagnostic accurarcy measures of structured self-monitoring 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
- Secondary Outcome Measures
Name Time Method Changes in ST-Segment of the ECG during ergometry Day 1 at 760 and 3100m Altitude-induced change in the ST-Segment of the ECG assessed during a maximal ergometry test performed at 760 and 3100m
Spirometric measurement of forced expiratory volume in one second Day 2 at 760 and 3100m Altitude-induced change in the forced expiratory volume in one between 760 and 3100m
Six-minute walk distance in meters Day 2 at 760 and 3100m Altitude-induced change in the six-minute walk distance assessed by the six-minute walk test performed at 760 and 3100m
Arterial partial pressure of oxygen Day 2 at 760 and 3100m Altitude-induced change in arterial partial pressure of oxygen assessed by arterial blood gas puncture at 760 and 3100m
Altitude-related illness, incidence Day 1 to 3 at 3100m Incidence of ARI during the stay at 3100 m.
ARI is 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 physicianAcute mountain sickness severity assessed by the Lake Louise score Day 1 to 3 at 3100m The severity of acute mountain sickness will be assessed by the Lake Louise questionnaire. The severity will be calculated when the presence of headache and at least one of the following symptoms is present: gastrointestinal upset, fatigue or weakness and dizziness or lightheadedness. Each of the four questions is asked with the corresponding 0 to 3 rating of the response (0 = Not present, 1 = mild, 2 = moderate, 3 = severe). The sum of the responses on these questions is then calculated, resulting in the AMS severity.
Trial Locations
- Locations (1)
National Center of Cardiology and Internal Medicine
🇰🇬Bishkek, Kyrgyzstan