High Altitude Clinical Trial
Official title:
Does Hypoxia-altitude Testing at Lowland Predict Altitude Related Adverse Health Effects in COPD Patients Traveling to 3100m?
NCT number | NCT04915378 |
Other study ID # | 01-2021-SU-HAST |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | May 31, 2022 |
Verified date | June 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 75 |
Est. completion date | May 31, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Kyrgyzstan | National Center of Cardiology and Internal Medicine | Bishkek |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | National Center of Cardiology and Internal Medicine, Kyrgyz Republic |
Kyrgyzstan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | pulse oximetry (SpO2) | At 760 m and 3100m | 3 days | |
Secondary | six minute walking distance | At 760 m and 3100m | 3 days | |
Secondary | pulmonary function | Spirometry and single breath carbon monoxide diffusing capacity will be measured | 3 days | |
Secondary | 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) | 2 nights | |
Secondary | 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 | 3 days | |
Secondary | 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. | 3 days | |
Secondary | 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. | 3 days | |
Secondary | Arterial blood gas analysis | To assess arterial partial pressure of oxygen (PaO2) at 760 m and 3100m | 3 days | |
Secondary | 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). | 2 nights | |
Secondary | Blood pressure | At 760 m and 3100m. | 3 days |
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