Hypoxic Respiratory FailureNCT03082105
Snow Physical Properties and Human Ventilatory Response
A study testing Breathing in snow in people with Hypoxic Respiratory Failure and Hypercapnic Respiratory Failure, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial summary
Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxic Respiratory Failure, Hypercapnic Respiratory Failure, Avalanche Burial
- What is being tested?
- Breathing in snow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2013to 9 Mar 2014
- 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
- Healthy volunteers with an age above 18yr-old, physically active.
- Volunteers have been informed and have signed consent.
Who cannot join
- Lack of consent.
- Chronic previous illness of the respiratory tract or of the cardiovascular system.
- Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).
- Eurac employees.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Mountain Emergency Medicine, Eurac Research
Bolzano, Bz, 39100
About this study
Official title: Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia
Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence of different snow physical properties on the development of hypoxia and hypercapnia in subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L. Every subject performed three tests on different days with varying snow characteristics. Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea, dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard methods and micro-computed tomography (CT) analysis, and permeability and penetration with the snow micro-penetrometer (SMP).
- Conditions
- Hypoxic Respiratory Failure, Hypercapnic Respiratory Failure, Avalanche Burial, Snow Physical Properties
- Being tested
- Breathing in snow
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing in snowOther
Breathing in snow with different physical properties
| Study group | Role | What they receive |
|---|---|---|
| Winter snow | Experimental | First test series breathing in dry snow in winter Receives: Other: Breathing in snow |
| Intermediate snow | Experimental | Second test series breathing in dry/wet snow in intermediate season Receives: Other: Breathing in snow |
| Spring snow | Experimental | Third test series breathing in very wet snow in spring Receives: Other: Breathing in snow |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 (%)
Continuous monitoring
Measured: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Secondary outcomes (4)
EtCO2 (mmHg)
Continuous monitoring
Measured: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Cause of interruption
SpO2 <75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache)
Measured: Timepoint immediately before interruption of snow-breathing phase (max 30min)
VE (L/min)
Continuous monitoring
Measured: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
rSO2 (%)
Continuous monitoring
Measured: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Dec 2013
- Primary completion9 Mar 2014
- Study completion9 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Respiratory FailureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
- Investigators
- Giacomo Strapazzon, MD PhD, Study director, Eurac ResearchHermann Brugger, MD, Study director, Eurac Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082105
- Sponsor's protocol ID
- V/16/13
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brugger H, Sumann G, Meister R, Adler-Kastner L, Mair P, Gunga HC, Schobersberger W, Falk M. Hypoxia and hypercapnia during respiration into an artificial air pocket in snow: implications for avalanche survival. Resuscitation. 2003 Jul;58(1):81-8. doi: 10.1016/s0300-9572(03)00113-8.
PubMed 12867313Haegeli P, Falk M, Brugger H, Etter HJ, Boyd J. Comparison of avalanche survival patterns in Canada and Switzerland. CMAJ. 2011 Apr 19;183(7):789-95. doi: 10.1503/cmaj.101435. Epub 2011 Mar 21.
PubMed 21422139
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia
- ClinicalTrials.gov ID
- NCT03082105
- Acronym / sponsor ID
- V/16/13
- Conditions
- Hypoxic Respiratory Failure, Hypercapnic Respiratory Failure, Avalanche Burial, Snow Physical Properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 9 Mar 2014 (actual)
- Study completion
- 9 Mar 2014 (actual)
- First posted
- 17 Mar 2017 (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.
Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence of different snow physical properties on the development of hypoxia and hypercapnia in subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L. Every subject performed three tests on different days with varying snow characteristics. Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea, dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard methods and micro-computed tomography (CT) analysis, and permeability and penetration with the snow micro-penetrometer (SMP).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Winter snow | Experimental | Other: Breathing in snowFirst test series breathing in dry snow in winter |
| Intermediate snow | Experimental | Other: Breathing in snowSecond test series breathing in dry/wet snow in intermediate season |
| Spring snow | Experimental | Other: Breathing in snowThird test series breathing in very wet snow in spring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers with an age above 18yr-old, physically active.
- Volunteers have been informed and have signed consent.
Key exclusion criteria (4 listed)
- Lack of consent.
- Chronic previous illness of the respiratory tract or of the cardiovascular system.
- Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).
- Eurac employees.
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 in snowBreathing in snow with different physical properties | Other | Intermediate snow, Spring snow, Winter snow |
Primary outcome
SpO2 (%)
Time frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Continuous monitoring
4 secondary outcomes
EtCO2 (mmHg)
Time frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Cause of interruption
Time frame: Timepoint immediately before interruption of snow-breathing phase (max 30min)
VE (L/min)
Time frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
rSO2 (%)
Time frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
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 17 Mar 2017.
- Background: PubMed 12867313Brugger H, Sumann G, Meister R, Adler-Kastner L, Mair P, Gunga HC, Schobersberger W, Falk M. Hypoxia and hypercapnia during respiration into an artificial air pocket in snow: implications for avalanche survival. Resuscitation. 2003 Jul;58(1):81-8. doi: 10.1016/s0300-9572(03)00113-8.
- Background: PubMed 21422139Haegeli P, Falk M, Brugger H, Etter HJ, Boyd J. Comparison of avalanche survival patterns in Canada and Switzerland. CMAJ. 2011 Apr 19;183(7):789-95. doi: 10.1503/cmaj.101435. Epub 2011 Mar 21.
- Individual participant dataSharing planned: No
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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.
Giacomo Strapazzon, MD PhD study director
Eurac Research
Hermann Brugger, MD study director
Eurac Research
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 in snow in people with Hypoxic Respiratory Failure and Hypercapnic Respiratory Failure, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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 4 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 17 Mar 2017. 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 Italy. 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?
SpO2 (%) (time frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082105, which also lists 2 linked publications.
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 17 Mar 2017; AzTrials last refreshed its copy on 28 Oct 2026.