Clinical trial NCT03957759: Early Signs of Altitude Illness in Patients With COPD
Official title: Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Altitude
Hypobaric hypoxia
Altitude-related illness
Prevention
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2019-05-21
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD, FEV1 40-80% predicted living at low altitude.

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.

Eligibility criteria: Inclusion criteria

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92%, PaCO2 \<6 kPa at 760 m.
* Born, raised and currently living at low altitude (\<800 m).
* Written informed consent.

Exclusion criteria

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1 \<40% predicted; oxygen saturation on room air \<92% or hypercapnia at 760 m).
* Other lung disease or disorder of control of breathing
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day)

Primary outcomes:
measure: Diagnostic accurarcy measures of structured self-monitoring
timeFrame: Day 1 to 3 at 3100m
Secondary outcomes:
measure: Acute mountain sickness severity assessed by the Lake Louise score
timeFrame: Day 1 to 3 at 3100m
measure: Altitude-related illness, incidence
timeFrame: Day 1 to 3 at 3100m
measure: Spirometric measurement of forced expiratory volume in one second
timeFrame: Day 2 at 760 and 3100m
measure: Arterial partial pressure of oxygen
timeFrame: Day 2 at 760 and 3100m
measure: Six-minute walk distance in meters
timeFrame: Day 2 at 760 and 3100m
measure: Changes in ST-Segment of the ECG during ergometry
timeFrame: Day 1 at 760 and 3100m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References: