Early Signs of Altitude Illness in Patients With COPD

NCT ID: NCT03957759

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2021-08-08

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients

Structured self-monitoring during an altitude ascent and stay at high altitude

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

OTHER_GOV

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch, MD

Role: STUDY_CHAIR

University of Zurich

Talant M Sooronbaev, MD

Role: STUDY_DIRECTOR

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Locations

National Center of Cardiology and Internal Medicine

Bishkek, , Kyrgyzstan

Countries

Kyrgyzstan

Other Identifiers

01-8/464-14

Identifier Type: -

Identifier Source: org_study_id