Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT05262894
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2022-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The length of breathing', 'timeFrame': 'Continuously within up to 20 minute interval from the beginning of the breathing experiment', 'description': 'Time to termination of the breathing experiment due to the decision of the tested subject, or determined by high end-tidal carbon dioxide value or by the order by the clinician assessing the health status of the subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['snow', 'avalanche', 'hypercapnia', 'diffusion'], 'conditions': ['Accident Caused by Snow Avalanche']}, 'referencesModule': {'references': [{'pmid': '26666523', 'type': 'BACKGROUND', 'citation': 'Roubik K, Sieger L, Sykora K. Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover Study. PLoS One. 2015 Dec 14;10(12):e0144332. doi: 10.1371/journal.pone.0144332. eCollection 2015.'}, {'pmid': '35136116', 'type': 'BACKGROUND', 'citation': 'Roubik K, Sykora K, Sieger L, Ort V, Horakova L, Walzel S. Perlite is a suitable model material for experiments investigating breathing in high density snow. Sci Rep. 2022 Feb 8;12(1):2070. doi: 10.1038/s41598-022-06015-y.'}]}, 'descriptionModule': {'briefSummary': 'The study is aimed at investigation of respiratory gases propagation in snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow.', 'detailedDescription': 'The study is aimed at investigation of respiratory gases (oxygen and carbon dioxide) propagation in the simulated avalanche snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow. A special apparatus was created for sampling and measurement of gas concentrations and to assure stable geometry of the experiment required for data evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy and fit volunteers, classified as The American Society of Anesthesiologists class I\n* without a smoking history\n\nExclusion Criteria:\n\n* Tiffeneau Index less than 0.70\n* any cardiovascular or respiratory condition'}, 'identificationModule': {'nctId': 'NCT05262894', 'acronym': 'GasProp', 'briefTitle': 'Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow', 'orgStudyIdInfo': {'id': '2022-Bradler'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breathing in the snow', 'description': 'Breathing in the snow using a specially designed apparatus and measuring the respiratory gases distribution in snow.', 'interventionNames': ['Other: extreme hypercapnia induced by ventilation insufficiency']}], 'interventions': [{'name': 'extreme hypercapnia induced by ventilation insufficiency', 'type': 'OTHER', 'description': 'Re-breathing of gas by breathing into the simulated avalanche snow', 'armGroupLabels': ['Breathing in the snow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '272 01', 'city': 'Kladno', 'country': 'Czechia', 'facility': 'Czech Technical University, Faculty of Biomedical Engineering', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}], 'overallOfficials': [{'name': 'Karel Roubik, prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague, Fac. of Biomedical Engineering'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}