Hypoxia Altitude Simulation TestNCT04915378
Hypoxia-altitude Testing to Predict Altitude Related Adverse Health Effects in Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of Hypoxia Altitude Simulation Test and High Altitude, run by University of Zurich at 1 site in Kyrgyzstan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypoxia Altitude Simulation Test, High Altitude
- What is being tested?
- hypoxia altitude simulation test (HAST) at 760m and High Altitude (3100m)
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 1 Jun 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center of Cardiology and Internal Medicine
Bishkek, 720040
About this study
Official title: Does Hypoxia-altitude Testing at Lowland Predict Altitude Related Adverse Health Effects in COPD Patients Traveling to 3100m?
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
Read the detailed description
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.
- Conditions
- Hypoxia Altitude Simulation Test, High Altitude
- Being tested
- hypoxia altitude simulation test (HAST) at 760m, High Altitude (3100m)
- Keywords
- Hypoxia altitude simulation test (HAST), Chronic obstructive pulmonary disease, Mountain Sickness, Altitude-related adverse health effects (ARAHE)
- Medical subject headings
- Altitude Sickness, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxia altitude simulation test (HAST) at 760mOther
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 or surgery
High Altitude (3100m) exposure for 2 days
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (10)
pulse oximetry (SpO2)
At 760 m and 3100m
Measured: 3 days
six minute walking distance
At 760 m and 3100m
Measured: 3 days
pulmonary function
Spirometry and single breath carbon monoxide diffusing capacity will be measured
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 days
Arterial blood gas analysis
To assess arterial partial pressure of oxygen (PaO2) at 760 m and 3100m
Measured: 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).
Measured: 2 nights
Blood pressure
At 760 m and 3100m.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia Altitude Simulation TestStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine, Kyrgyz Republic
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof, Study chair, University Hospital, Zürich, SwitzerlandTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915378
- Sponsor's protocol ID
- 01-2021-SU-HAST
- Status last verified
- Jun 2022
- First submitted
- 31 May 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hypoxia-altitude Testing at Lowland Predict Altitude Related Adverse Health Effects in COPD Patients Traveling to 3100m?
- ClinicalTrials.gov ID
- NCT04915378
- Acronym / sponsor ID
- 01-2021-SU-HAST
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine, Kyrgyz Republic
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypoxia altitude simulation test (HAST) at 760mNormobaric 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). | Other | – |
| High Altitude (3100m)High Altitude (3100m) exposure for 2 days | Procedure or surgery | – |
Primary outcome
PaO2 <6.6 kPa or SpO2 < 85% during a HAST in identifying participants with ARAHE
Time frame: 3 days
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
10 secondary outcomes
pulse oximetry (SpO2)
Time frame: 3 days
six minute walking distance
Time frame: 3 days
pulmonary function
Time frame: 3 days
Nocturnal respiratory polygraphies
Time frame: 2 nights
Borg Dyspnea Scale
Time frame: 3 days
Lake Louise score (2018 version)
Time frame: 3 days
Environmental Symptoms Questionnaire cerebral score
Time frame: 3 days
Arterial blood gas analysis
Time frame: 3 days
The Karolinska sleepiness scale
Time frame: 2 nights
Blood pressure
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Hypoxia Altitude Simulation Test
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Study of the Effects of Acute Exposure to Moderate Altitude Hypoxia on Prospective Memory.
Hypoxia, Hypoxia Brain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Ulrich, Prof study chair
University Hospital, Zürich, Switzerland
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia Altitude Simulation Test and High Altitude, run by University of Zurich at 1 site in Kyrgyzstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 <6.6 kPa or SpO2 < 85% during a HAST in identifying participants with ARAHE (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.