Early Signs of Altitude Illness in Patients With COPD

NCT03957759 | Completed

• 1 other identifier: 01-8/464-14
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Altitude; Hypobaric hypoxia; Altitude-related illness; Prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (1)

COPD patients

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

Interventions

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).

COPD patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with COPD, FEV1 40-80% predicted living at low altitude.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Location

Related Publications (1)

• 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.

  PMID: 41433778 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konrad E Bloch, MD

  University of Zurich

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 21, 2019
• Study Start: May 20, 2019
• Primary Completion: August 8, 2021
• Study Completion: August 8, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

KY (1)