Acute Mountain SicknessNCT01468194
Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude
A study testing Breathing procedure 1 and Breathing procedure 2 in people with Acute Mountain Sickness, run by University of Giessen at 1 site in Germany.
Trial summary
In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Breathing procedure 1 and Breathing procedure 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Nov 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- acute clinically significant inter-current diseases
Trial locations and contacts
1 site in 1 country.
About this study
In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.
Read the detailed description
Acute mountain sickness (AMS) is a pathological effect of high altitude on humans caused by acute exposure to low partial pressure of oxygen at high altitude. It commonly occurs above 2500 meters of altitude. AMS appears as a collection of nonspecific symptoms acquired at high altitude or in low air pressure resembling a case of "flu, carbon monoxide poisoning, or a hangover".
It is caused by a drop in pressure and lowering partial pressure of oxygen during increasing altitude. The direct consequence of those changes is a hypoxic pulmonary vasoconstriction (Euler-Lijestrand-mechanism). In addition a rise in pulmonary blood pressure (Hypertonia) can occur so that there is a higher risk of developing a high altitude pulmonary edema (HAPE).
In this investigation the investigators are exploring whether different types of breathing procedures can improve the peripheral oxygen saturation. We are comparing breathing with no regulation with two different procedures of hyperventilation during trekking in different altitudes. Procedure 1 (hyperventilation 1) describes inhalation during one step and exhalation during the next step. Procedure 2 (hyperventilation 2) describes inhalation and exhalation during one step.
The effect of the different breathing procedures can be quantified measuring the peripheral oxygen saturation. In addition the investigators are comparing the breathing rate and the minute ventilation as well as the expiratory end-tidal CO2-partial pressure of the three different breathing procedures.
Furthermore, the investigators are examining the ability to concentrate in order to quantify the effect of AMS on organ functions.
- Conditions
- Acute Mountain Sickness
- Being tested
- Breathing procedure 1, Breathing procedure 2
- Keywords
- AMS, HAPE, high altitude, oxygen, saturation, mountain, climbing, breathing
- Medical subject headings
- Altitude Sickness, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing procedure 1Other
inhalation during one step, exhalation during the next step
Breathing procedure 2Other
inhalation and exhalation during one step
| Study group | Role | What they receive |
|---|---|---|
| Breathing procedure 1 | Experimental | Walking with breathing procedure "1". Receives: Other: Breathing procedure 1 |
| Breathing procedure 2 | Experimental | Walking with breathing procedure "2". Receives: Other: Breathing procedure 2 |
| Control group | No intervention | Walking without any reglementation of breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of peripheral oxygen saturation
change of peripheral oxygen saturation under different breathing procedures in different altitudes
Measured: immediate after intervention
Secondary outcomes (2)
change of breathing parameters
change of breathing parameters under different breathing procedures in different altitudes
- breathing rate
- minute ventilation
- expiratory end-tidal CO2-partial pressure
Measured: immediate after intervention
change of cognition
change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes
Measured: immediate after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- MVZ für Laboratoriumsmedizin Koblenz
- Responsible party
- Principal investigator, Andree Hillebrecht, University of Giessen
- Investigators
- Gabor Szalay, Dr. med., Principal investigator, Trauma surgery - University hospital Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468194
- Sponsor's protocol ID
- Gi-04-2011
- Status last verified
- Nov 2011
- First submitted
- 9 Oct 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude
- ClinicalTrials.gov ID
- NCT01468194
- Acronym / sponsor ID
- Gi-04-2011
- Conditions
- Acute Mountain Sickness
- Keywords
- AMS, HAPE, high altitude, oxygen, saturation, mountain, climbing, breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- MVZ für Laboratoriumsmedizin Koblenz
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Nov 2011 (estimated)
- 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.
In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.
Detailed description
Acute mountain sickness (AMS) is a pathological effect of high altitude on humans caused by acute exposure to low partial pressure of oxygen at high altitude. It commonly occurs above 2500 meters of altitude. AMS appears as a collection of nonspecific symptoms acquired at high altitude or in low air pressure resembling a case of "flu, carbon monoxide poisoning, or a hangover".
It is caused by a drop in pressure and lowering partial pressure of oxygen during increasing altitude. The direct consequence of those changes is a hypoxic pulmonary vasoconstriction (Euler-Lijestrand-mechanism). In addition a rise in pulmonary blood pressure (Hypertonia) can occur so that there is a higher risk of developing a high altitude pulmonary edema (HAPE).
In this investigation the investigators are exploring whether different types of breathing procedures can improve the peripheral oxygen saturation. We are comparing breathing with no regulation with two different procedures of hyperventilation during trekking in different altitudes. Procedure 1 (hyperventilation 1) describes inhalation during one step and exhalation during the next step. Procedure 2 (hyperventilation 2) describes inhalation and exhalation during one step.
The effect of the different breathing procedures can be quantified measuring the peripheral oxygen saturation. In addition the investigators are comparing the breathing rate and the minute ventilation as well as the expiratory end-tidal CO2-partial pressure of the three different breathing procedures.
Furthermore, the investigators are examining the ability to concentrate in order to quantify the effect of AMS on organ functions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breathing procedure 1 | Experimental | Other: Breathing procedure 1Walking with breathing procedure "1". |
| Breathing procedure 2 | Experimental | Other: Breathing procedure 2Walking with breathing procedure "2". |
| Control group | No intervention | –Walking without any reglementation of breathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- acute clinically significant inter-current diseases
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 |
|---|---|---|
| Breathing procedure 1inhalation during one step, exhalation during the next step | Other | Breathing procedure 1 |
| Breathing procedure 2inhalation and exhalation during one step | Other | Breathing procedure 2 |
Primary outcome
change of peripheral oxygen saturation
Time frame: immediate after intervention
change of peripheral oxygen saturation under different breathing procedures in different altitudes
2 secondary outcomes
change of breathing parameters
Time frame: immediate after intervention
change of cognition
Time frame: immediate after intervention
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 9 Nov 2011.
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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.
Gabor Szalay, Dr. med. principal investigator
Trauma surgery - University hospital Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing procedure 1 and Breathing procedure 2 in people with Acute Mountain Sickness, run by University of Giessen at 1 site in Germany.
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 0 inclusion and 1 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 9 Nov 2011. 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 Germany. 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?
change of peripheral oxygen saturation (time frame: immediate after intervention). 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 9 Nov 2011; AzTrials last refreshed its copy on 26 Oct 2026.