Trials / Completed
CompletedNCT03957759
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 153 (actual)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Structured self-monitoring during an altitude ascent and stay at high altitude | 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). |
Timeline
- Start date
- 2019-05-20
- Primary completion
- 2021-08-08
- Completion
- 2021-08-08
- First posted
- 2019-05-21
- Last updated
- 2022-11-29
Locations
1 site across 1 country: Kyrgyzstan
Source: ClinicalTrials.gov record NCT03957759. Inclusion in this directory is not an endorsement.