Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT01468194
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2011-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-10-09', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of peripheral oxygen saturation', 'timeFrame': 'immediate after intervention', 'description': 'change of peripheral oxygen saturation under different breathing procedures in different altitudes'}], 'secondaryOutcomes': [{'measure': 'change of breathing parameters', 'timeFrame': 'immediate after intervention', 'description': 'change of breathing parameters under different breathing procedures in different altitudes\n\n* breathing rate\n* minute ventilation\n* expiratory end-tidal CO2-partial pressure'}, {'measure': 'change of cognition', 'timeFrame': 'immediate after intervention', 'description': 'change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AMS', 'HAPE', 'high altitude', 'oxygen', 'saturation', 'mountain', 'climbing', 'breathing'], 'conditions': ['Acute Mountain Sickness']}, 'descriptionModule': {'briefSummary': 'In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.', 'detailedDescription': 'Acute mountain sickness (AMS) is a pathological effect of high altitude on humans caused by acute exposure to low partial pressure of oxygen at high altitude. It commonly occurs above 2500 meters of altitude. AMS appears as a collection of nonspecific symptoms acquired at high altitude or in low air pressure resembling a case of "flu, carbon monoxide poisoning, or a hangover".\n\nIt is caused by a drop in pressure and lowering partial pressure of oxygen during increasing altitude. The direct consequence of those changes is a hypoxic pulmonary vasoconstriction (Euler-Lijestrand-mechanism). In addition a rise in pulmonary blood pressure (Hypertonia) can occur so that there is a higher risk of developing a high altitude pulmonary edema (HAPE).\n\nIn this investigation the investigators are exploring whether different types of breathing procedures can improve the peripheral oxygen saturation. We are comparing breathing with no regulation with two different procedures of hyperventilation during trekking in different altitudes. Procedure 1 (hyperventilation 1) describes inhalation during one step and exhalation during the next step. Procedure 2 (hyperventilation 2) describes inhalation and exhalation during one step.\n\nThe effect of the different breathing procedures can be quantified measuring the peripheral oxygen saturation. In addition the investigators are comparing the breathing rate and the minute ventilation as well as the expiratory end-tidal CO2-partial pressure of the three different breathing procedures.\n\nFurthermore, the investigators are examining the ability to concentrate in order to quantify the effect of AMS on organ functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* acute clinically significant inter-current diseases'}, 'identificationModule': {'nctId': 'NCT01468194', 'briefTitle': 'Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'orgStudyIdInfo': {'id': 'Gi-04-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breathing procedure 1', 'description': 'Walking with breathing procedure "1".', 'interventionNames': ['Other: Breathing procedure 1']}, {'type': 'EXPERIMENTAL', 'label': 'Breathing procedure 2', 'description': 'Walking with breathing procedure "2".', 'interventionNames': ['Other: Breathing procedure 2']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Walking without any reglementation of breathing'}], 'interventions': [{'name': 'Breathing procedure 1', 'type': 'OTHER', 'description': 'inhalation during one step, exhalation during the next step', 'armGroupLabels': ['Breathing procedure 1']}, {'name': 'Breathing procedure 2', 'type': 'OTHER', 'description': 'inhalation and exhalation during one step', 'armGroupLabels': ['Breathing procedure 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35394', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Gabor Szalay, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trauma surgery - University hospital Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'MVZ für Laboratoriumsmedizin Koblenz', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Akademischer Rat', 'investigatorFullName': 'Andree Hillebrecht', 'investigatorAffiliation': 'University of Giessen'}}}}