Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-03-12 @ 2:53 AM
Study NCT ID:
NCT01898858
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006935', 'term': 'Hypercapnia'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-07-11', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Artery Pulmonary Pressure(sPAP) (echocardiography, Cardiac output (impedancemetry), Cardiorespiratory parameters', 'timeFrame': 'at the end of the 30th minutes constant load exercise', 'description': 'At rest and during exercise for each condition'}], 'secondaryOutcomes': [{'measure': 'Dyspnea and muscle leg discomfort using a Borg Scale', 'timeFrame': 'at the end of the 30th minutes constant load exercise', 'description': 'In each conditions at rest and during exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Vascular Sensibility in Hypoxia', 'Hypercapnia', 'Hypoxia and Hypercapnia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a short constant load exercise in 4 conditions :\n\n* normoxia\n* hypoxia\n* hypercapnia\n* association hypoxia and hypercapnia'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* healthy male\n* exercise capacity between 100 and 130 % of theorical values\n\nExclusion criteria:\n\n* smoker\n* headache\n* impossibility to perform an exercise test\n* no tricuspid regurgitation on the echocardiography'}, 'identificationModule': {'nctId': 'NCT01898858', 'acronym': 'H2PAP', 'briefTitle': 'Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic', 'orgStudyIdInfo': {'id': '5546'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HYPOXIA', 'interventionNames': ['Device: Hypoxia inhalation (Altitrainer NP 190)']}, {'label': 'HYPERCAPNIA', 'interventionNames': ['Device: Hypercapnia inhalation (Altitrainer NP 190)']}, {'label': 'HYPOXIA + HYPERCAPNIA', 'interventionNames': ['Device: Hypoxia and hypercapnia (Altitrainer NP 190)']}], 'interventions': [{'name': 'Hypercapnia inhalation (Altitrainer NP 190)', 'type': 'DEVICE', 'description': 'Hypercapnia inhalation using an Altitrainer NP 190', 'armGroupLabels': ['HYPERCAPNIA']}, {'name': 'Hypoxia and hypercapnia (Altitrainer NP 190)', 'type': 'DEVICE', 'description': 'Hypoxia and hypercapnia inhalation using an Altitrainer NP 190', 'armGroupLabels': ['HYPOXIA + HYPERCAPNIA']}, {'name': 'Hypoxia inhalation (Altitrainer NP 190)', 'type': 'DEVICE', 'description': 'Hypoxia inhalation using an Altitrainer NP 190', 'armGroupLabels': ['HYPOXIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'PISTEA Cristina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}