Accident Caused by Snow AvalancheNCT03911011
Physiological Values When Breathing in an Air-pocket. Mountain Lab 2019 (ML2019)
A study testing Fresh air in people with Accident Caused by Snow Avalanche, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The literature describes and report neurologic intact patients surviving an avalanche several hours after they were buried. The most important factor for surviving more than 15-35 min of burial is considered to be the presence of an air-filled space around the head and neck, termed an air pocket. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Accident Caused by Snow Avalanche
- What is being tested?
- Fresh air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 7 Mar 2019to 20 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject must be Healthy
- Subject must be non smoking
- Subject must have normal BMI
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gas Diffusion in and Out of an Air Pocket After a Simulated Snow Avalanche and Its Impacts on Human Physiological Parameters.
The literature describes and report neurologic intact patients surviving an avalanche several hours after they were buried. The most important factor for surviving more than 15-35 min of burial is considered to be the presence of an air-filled space around the head and neck, termed an air pocket. Little is known how the inspired air is influenced by the patients breathing and how oxygen and carbon dioxide diffuse through snow.
Read the detailed description
In a controlled and simulated avalanche scenario the investigators want to investigate how oxygen (O2) and carbon dioxide (CO2) diffuse and how rebreathing of CO2 in addition to mild hypoxia influence standardized physiological parameters in two scenarios: Fresh air and no fresh air delivered into the air pocket. The project is a field study designed to measure and document gas diffusion through snow. The outcome measures are: (1) Concentration of O2 and CO2 in the air pocket and 50 cm from the pocket. (2) Time interval for development of threshold values for concentration of O2 and CO2. The investigators will also monitor physiologic measures such as: Electrocardiogram (ECG), continuous invasive blood pressure, cerebral oximetry, continuous pulse oximetry, transthoracic impedance, and gas content in expired air. Subjective evaluation of comfort will also be scored. Twenty healthy young volunteers with written consent to participate will be used as test subjects.
The study may have a clinical consequence for better outcome, for victims of avalanches by providing additional air or oxygen close to the patient. The study will also measure specific body measures and spirometry.
- Conditions
- Accident Caused by Snow Avalanche
- Being tested
- Fresh air
- Keywords
- avalanche, survival, physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh airOther
Fresh air insufflation of 2 L/min toward mouth/nose.
| Study group | Role | What they receive |
|---|---|---|
| Fresh air | Active comparator | 2 litres of fresh air Receives: Other: Fresh air |
| no fresh air | No intervention | no supply of fresh air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Time to reaching a threshold of physiology parameters or time limit
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start7 Mar 2019
- Primary completion8 Jun 2019
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accident Caused by Snow AvalancheStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A field study designed as a crossover clinical trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital
- Responsible party
- Sponsor
- Investigators
- Hanne Klausen, PhD, Study director, Director, Department for Anaesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911011
- Sponsor's protocol ID
- 2018/2478
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2019
- Last updated
- 27 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Diffusion in and Out of an Air Pocket After a Simulated Snow Avalanche and Its Impacts on Human Physiological Parameters.
- ClinicalTrials.gov ID
- NCT03911011
- Acronym / sponsor ID
- 2018/2478
- Conditions
- Accident Caused by Snow Avalanche
- Keywords
- avalanche, survival, physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 10 Apr 2019 (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 literature describes and report neurologic intact patients surviving an avalanche several hours after they were buried. The most important factor for surviving more than 15-35 min of burial is considered to be the presence of an air-filled space around the head and neck, termed an air pocket. Little is known how the inspired air is influenced by the patients breathing and how oxygen and carbon dioxide diffuse through snow.
Detailed description
In a controlled and simulated avalanche scenario the investigators want to investigate how oxygen (O2) and carbon dioxide (CO2) diffuse and how rebreathing of CO2 in addition to mild hypoxia influence standardized physiological parameters in two scenarios: Fresh air and no fresh air delivered into the air pocket. The project is a field study designed to measure and document gas diffusion through snow. The outcome measures are: (1) Concentration of O2 and CO2 in the air pocket and 50 cm from the pocket. (2) Time interval for development of threshold values for concentration of O2 and CO2. The investigators will also monitor physiologic measures such as: Electrocardiogram (ECG), continuous invasive blood pressure, cerebral oximetry, continuous pulse oximetry, transthoracic impedance, and gas content in expired air. Subjective evaluation of comfort will also be scored. Twenty healthy young volunteers with written consent to participate will be used as test subjects.
The study may have a clinical consequence for better outcome, for victims of avalanches by providing additional air or oxygen close to the patient. The study will also measure specific body measures and spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A field study designed as a crossover clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Fresh air | Active comparator | Other: Fresh air2 litres of fresh air |
| no fresh air | No intervention | –no supply of fresh air |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be Healthy
- Subject must be non smoking
- Subject must have normal BMI
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Fresh airFresh air insufflation of 2 L/min toward mouth/nose. | Other | Fresh air |
Primary outcome
Time
Time frame: 25 minutes
Time to reaching a threshold of physiology parameters or time limit
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 Feb 2025.
- Individual participant dataSharing planned: No
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.
Hanne Klausen, PhD study director
Director, Department for Anaesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh air in people with Accident Caused by Snow Avalanche, run by Haukeland University Hospital at 1 site in Norway.
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 3 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 27 Feb 2025. 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 Norway. 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?
Time (time frame: 25 minutes). 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 Feb 2025.