Early Signs of Altitude Illness in Patients With COPD
Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study.
Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study.
Sponsor study identifier
observational
153
1 country
1
Study Start
May 20, 2019
Actual (reported)Primary Completion
August 8, 2021
Actual (reported)Study Completion
August 8, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 8, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2019
Actual (reported)May 20, 2019
Actual (reported)May 21, 2019
Actual (reported)August 8, 2021
Actual (reported)August 8, 2021
Actual (reported)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: * 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
Day 1 to 3 at 3100m
Acute mountain sickness severity assessed by the Lake Louise score
Day 1 to 3 at 3100m
Altitude-related illness, incidence
Day 1 to 3 at 3100m
Spirometric measurement of forced expiratory volume in one second
Day 2 at 760 and 3100m
Arterial partial pressure of oxygen
Day 2 at 760 and 3100m
Six-minute walk distance in meters
Day 2 at 760 and 3100m
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with COPD, FEV1 40-80% predicted living at low altitude.
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan
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.
Konrad E Bloch, MD
University of Zurich
Talant M Sooronbaev, MD
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
153 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2019
First Posted
May 21, 2019
Study Start
May 20, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 8, 2021
Actual (reported)Study Completion
August 8, 2021
Actual (reported)Last Updated
November 29, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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