Hypercapnic Respiratory Failure Clinical Trial
Official title:
Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia
Verified date | March 2017 |
Source | Institute of Mountain Emergency Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 12 |
Est. completion date | March 9, 2014 |
Est. primary completion date | March 9, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy volunteers with an age above 18yr-old, physically active. - Volunteers have been informed and have signed consent. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Mountain Emergency Medicine, Eurac Research | Bolzano | Bz |
Lead Sponsor | Collaborator |
---|---|
Institute of Mountain Emergency Medicine | Medical University Innsbruck |
Italy,
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. — View Citation
Haegeli 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SpO2 (%) | Continuous monitoring | 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 | EtCO2 (mmHg) | Continuous monitoring | 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 | Cause of interruption | SpO2 <75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache) | Timepoint immediately before interruption of snow-breathing phase (max 30min) | |
Secondary | VE (L/min) | Continuous monitoring | 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 | rSO2 (%) | Continuous monitoring | 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 |
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