Hypoxia-altitude Testing to Predict Altitude Related Adverse Health Effects in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT04915378 | Completed

• 1 other identifier: 01-2021-SU-HAST
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The predictive value of the hypoxia altitude simulation test (HAST) or other baseline values to predict altitude-related adverse health effects (ARAHE) is not established. To address this gap, the main goals of this investigation will be 1) to evaluate the diagnostic accuracy of the HAST in identifying individuals that will experience ARAHE during altitude travel and 2) to establish prediction models incorporating other commonly assessed clinical characteristics either alone or in combination with the HAST as predictors of ARAHE in altitude travelers. Hypotheses: In lowlanders with COPD, a PaO2 \<6.6 kPa or another cutoff of PaO2 or SpO2 at the end of the HAST, at rest or during exertion and/or clinical variables including symptoms, pulmonary function indices, 6-min walk distance (6MWD), either alone or combined to a multivariable model, will predict ARAHE during a sojourn of 2 days at 3100m with accuracy greater than chance

Conditions

Hypoxia Altitude Simulation Test; High Altitude

Keywords

Hypoxia altitude simulation test (HAST); Chronic obstructive pulmonary disease; Mountain Sickness; Altitude-related adverse health effects (ARAHE)

Outcome Measures

Primary Outcomes (1)

• PaO2 <6.6 kPa or SpO2 < 85% during a HAST in identifying participants with ARAHE

  Accuracy of a PaO2 \<6.6 kPa during a HAST in identifying participants with ARAHE during the ascent to and stay for 2 days at 3'100 m

  3 days

Secondary Outcomes (10)

• pulse oximetry (SpO2)

  3 days

• six minute walking distance

  3 days

• pulmonary function

  3 days

• Nocturnal respiratory polygraphies

  2 nights

• Borg Dyspnea Scale

  3 days

Interventions

hypoxia altitude simulation test (HAST) at 760m OTHER

Normobaric hypoxia at a FiO2 of 15.1% will be generated by the Everest Summit II altitude generator (Hypoxico Altitude Training Systems, Bickenbach, Germany) and delivered to the patients face via tubes and a tightly fitted mask. Patients will be seated comfortably in a chair and fitted with a full-face mask equipped with a one-way valve. After a baseline period of quiet rest of 5-10 min with ambient air breathing and installation of equipment, patients will breath the hypoxic air mixture via a tightly fitted facial mask. They will be monitored with a finger-tip pulseoximetry to continuously assess SpO2 and heart rate. After at least 15' and steady-state values of the SpO2 (±1%) for at least 5' arterial blood gases will be drawn from a radial artery and immediately analyzed (RapidPoint 500, Siemens, Zürich, Switzerland).

High Altitude (3100m) PROCEDURE

High Altitude (3100m) exposure for 2 days

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD-patients living in the Bishkek area (mean altitude 760m) will be recruited among patients of the outpatient clinic of the National Center for Cardiology and Internal Medicine.

You may qualify if:

• Men and women, age 35-75 y, living at low altitude (\<800 m).
• COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, FEV1 40-80% predicted, pulse oximetry ≥92%, PaCO2 \<6 kPa, breathing ambient air at 760 m.

You may not qualify if:

• COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
• Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index \>35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (\>20 cigarettes per day).
• Renal failure and/or allergy to sulfonamides.

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine, Kyrgyz Republic: collaborator

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Altitude Sickness; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvia Ulrich, Prof

  University Hospital, Zürich, Switzerland

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: May 31, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)