Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-09 @ 3:37 PM
Study NCT ID:
NCT03082105
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Snow Physical Properties and Human Ventilatory Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012914', 'term': 'Snow'}], 'ancestors': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D055907', 'term': 'Climatic Processes'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2 (%)', 'timeFrame': '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', 'description': 'Continuous monitoring'}], 'secondaryOutcomes': [{'measure': 'EtCO2 (mmHg)', 'timeFrame': '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', 'description': 'Continuous monitoring'}, {'measure': 'Cause of interruption', 'timeFrame': 'Timepoint immediately before interruption of snow-breathing phase (max 30min)', 'description': 'SpO2 \\<75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache)'}, {'measure': 'VE (L/min)', 'timeFrame': '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', 'description': 'Continuous monitoring'}, {'measure': 'rSO2 (%)', 'timeFrame': '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', 'description': 'Continuous monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxic Respiratory Failure', 'Hypercapnic Respiratory Failure', 'Avalanche Burial', 'Snow Physical Properties']}, 'referencesModule': {'references': [{'pmid': '12867313', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21422139', 'type': 'BACKGROUND', '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. Epub 2011 Mar 21.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers with an age above 18yr-old, physically active.\n* Volunteers have been informed and have signed consent.\n\nExclusion Criteria:\n\n* Lack of consent.\n* Chronic previous illness of the respiratory tract or of the cardiovascular system.\n* Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).\n* Eurac employees.'}, 'identificationModule': {'nctId': 'NCT03082105', 'briefTitle': 'Snow Physical Properties and Human Ventilatory Response', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mountain Emergency Medicine'}, 'officialTitle': 'Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia', 'orgStudyIdInfo': {'id': 'V/16/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Winter snow', 'description': 'First test series breathing in dry snow in winter', 'interventionNames': ['Other: Breathing in snow']}, {'type': 'EXPERIMENTAL', 'label': 'Intermediate snow', 'description': 'Second test series breathing in dry/wet snow in intermediate season', 'interventionNames': ['Other: Breathing in snow']}, {'type': 'EXPERIMENTAL', 'label': 'Spring snow', 'description': 'Third test series breathing in very wet snow in spring', 'interventionNames': ['Other: Breathing in snow']}], 'interventions': [{'name': 'Breathing in snow', 'type': 'OTHER', 'description': 'Breathing in snow with different physical properties', 'armGroupLabels': ['Intermediate snow', 'Spring snow', 'Winter snow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Bolzano', 'state': 'Bz', 'country': 'Italy', 'facility': 'Institute of Mountain Emergency Medicine, Eurac Research', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}], 'overallOfficials': [{'name': 'Giacomo Strapazzon, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eurac Research'}, {'name': 'Hermann Brugger, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eurac Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mountain Emergency Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University Innsbruck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}