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
Altitude or air travel has become increasingly popular for recreational and professional reasons. Chronic obstructive pulmonary disease (COPD) affects up to 12% of adults worldwide and is associated with progressive hypoxemia, especially during exercise, due to respiratory mechanical constraints, airway obstruction and increasing pulmonary hypertension (PH). COPD patients are at increased risk of ARAHE including acute mountain sickness (AMS) and severe hypoxemia. Factors assessed at lowland that would predict ARAHE of COPD patients exposed to a hypobaric hypoxic environment at altitude or during air travel would be highly warranted. During the HAST COPD-patients are exposed to an inspiratory oxygen fraction (FiO2) of 15.1% corresponding to an altitude of ≈ 2500m and this test was designed to predict deoxygenation at altitude. The predictive value of the HAST or other baseline values to predict 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. For this diagnostic accuracy study, COPD-patients with an FEV1 40-80% predicted living \< 1000 m without severe hypoxemia (SpO2, \<92%), hypercapnia (PaCO2 \>6 kPa) or comorbidities will be recruited to traveling to and staying for two nights at 3100 m. At 760 m, the HAST will be performed, at 760 m and 3100 m symptoms, vital signs, SpO2, pulmonary function tests, 6MWD, sleep studies will be repetitively assessed. ARAHE will be defined if one of the following present: AMS with a Lake Louise questionnaire score \>4 including headache, or AMSc score ≥0.7, resting SpO2 \<80% \>30 min or \<75% for \>15 min; or exercise SpO2 \<75% for \>5 min accompanied by symptoms, any intercurrent illness including infections, hypertension, neurologic impairments, dyspnea or discomfort at rest requiring oxygen treatment, chest pain and/or ECG signs of cardiac ischemia.
Study Type
OBSERVATIONAL
Enrollment
75
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) exposure for 2 days
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan
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
Time frame: 3 days
pulse oximetry (SpO2)
At 760 m and 3100m
Time frame: 3 days
six minute walking distance
At 760 m and 3100m
Time frame: 3 days
pulmonary function
Spirometry and single breath carbon monoxide diffusing capacity will be measured
Time frame: 3 days
Nocturnal respiratory polygraphies
Real-time polygraphic data and videostreams will be transmitted to a control station to allow continuous observation by an investigator. This will allow detection of ARAHE at night (in particular severe hypoxemia)
Time frame: 2 nights
Borg Dyspnea Scale
Borg Scale for dyspnea from 0 to 10 (CR10) while 0 means "no dyspnea" and 10 means "highest dyspnea", to assess dyspnea at 760 m and 3100m
Time frame: 3 days
Lake Louise score (2018 version)
Which includes self-assessment of symptoms (headache, fatigue, gastrointestinal discomfort, dizziness), each rated from 0 (absent) to 3 (severe) at 760 m and 3100m.
Time frame: 3 days
Environmental Symptoms Questionnaire cerebral score
Environmental Symptoms Questionnaire cerebral score (AMSc) comprising 11 questions on symptoms rated from 0 (not at all) to 5 (extreme). The weighted sum of responses ranges from 0 to 5. At 760 m and 3100m.
Time frame: 3 days
Arterial blood gas analysis
To assess arterial partial pressure of oxygen (PaO2) at 760 m and 3100m
Time frame: 3 days
The Karolinska sleepiness scale
Sleepiness will be assessed by the Karolinska sleepiness scale at 3200 m. This is a 9-point scale (1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep).
Time frame: 2 nights
Blood pressure
At 760 m and 3100m.
Time frame: 3 days
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