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

NCT04915378 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2022-06-27

No results posted yet for this study

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

Interventions

OTHER

hypoxia altitude simulation test (HAST) at 760m

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).

PROCEDURE

High Altitude (3100m)

High Altitude (3100m) exposure for 2 days

Sponsors & Collaborators

  • National Center of Cardiology and Internal Medicine, Kyrgyz Republic

    collaborator UNKNOWN

  • University of Zurich

    lead OTHER

Principal Investigators

  • Silvia Ulrich, Prof · University Hospital, Zürich, Switzerland

  • Talant M Sooronbaev, MD · National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-09-01
Completion
2022-05-31

Countries

  • Kyrgyzstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04915378 on ClinicalTrials.gov