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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured self-monitoring during an altitude ascent and stay at high altitude | Diagnostic Test | Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m). |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accurarcy measures of structured self-monitoring | 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:
| Day 1 to 3 at 3100m |
| Measure | Description | Time Frame |
|---|---|---|
| Acute mountain sickness severity assessed by the Lake Louise score | 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. |
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Inclusion criteria
Exclusion criteria
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Patients with COPD, FEV1 40-80% predicted living at low altitude.
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| Name | Affiliation | Role |
|---|---|---|
| Konrad E Bloch, MD | University of Zurich | Study Chair |
| Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Cardiology and Internal Medicine | Bishkek | Kyrgyzstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41433778 | Derived | Furian M, Reiser AE, Mademilov M, Sutter S, Champigneulle B, Grimm M, Magdieva K, Beishenaliev AS, Sooronbaev TM, Ulrich S, Bloch KE. Self-monitoring symptoms and pulse oximetry to predict imminent altitude illness in patients with chronic obstructive pulmonary disease. Pulmonology. 2026 Dec;32(1):2588515. doi: 10.1080/25310429.2025.2588515. Epub 2025 Dec 23. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| Day 1 to 3 at 3100m |
| Altitude-related illness, incidence | Incidence of ARI during the stay at 3100 m. ARI is defined as the following:
| Day 1 to 3 at 3100m |
| Spirometric measurement of forced expiratory volume in one second | Altitude-induced change in the forced expiratory volume in one between 760 and 3100m | Day 2 at 760 and 3100m |
| Arterial partial pressure of oxygen | Altitude-induced change in arterial partial pressure of oxygen assessed by arterial blood gas puncture at 760 and 3100m | Day 2 at 760 and 3100m |
| Six-minute walk distance in meters | Altitude-induced change in the six-minute walk distance assessed by the six-minute walk test performed at 760 and 3100m | Day 2 at 760 and 3100m |
| Changes in ST-Segment of the ECG during ergometry | Altitude-induced change in the ST-Segment of the ECG assessed during a maximal ergometry test performed at 760 and 3100m | Day 1 at 760 and 3100m |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |