Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-10 @ 8:48 PM
Study NCT ID:
NCT02736006
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2016-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003665', 'term': 'Decompression Sickness'}], 'ancestors': [{'id': 'D001469', 'term': 'Barotrauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-12', 'studyFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous bubbles will be detected by precordial Doppler', 'timeFrame': '30 minutes after the dive', 'description': 'Venous bubbles will be detected by precordial Doppler'}], 'secondaryOutcomes': [{'measure': 'Vascular abnormality', 'timeFrame': '60 minutes after the dive', 'description': 'Assessement of microvascular reactivity by brachial artery flow mediated dilation'}, {'measure': 'Coagulation activation', 'timeFrame': '60 minutes after the dive', 'description': 'Assessment of blood coagulation factor after the dive'}, {'measure': 'Inflammatory activation', 'timeFrame': '60 minutes after the dive', 'description': 'Assessment of inflammatory factor after the dive'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alveolo-capillar membrane', 'decompression illness', 'diving', 'occupational'], 'conditions': ['Decompression Sickness']}, 'descriptionModule': {'briefSummary': 'Diving disorders and particularly Decompression sickness (DCS) represent a major concern in recreational and occupational pressure-related activities. As a result of decompression from higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues take part in embolism then resulting in DCS. Individual factors such as vascular or respiratory defects are now considered to increase the risk of this dysbarism disease.', 'detailedDescription': '2 groups of occupational divers will be separated after a fitness medical examination by regarding DLCO decrease or not.\n\nThe divers will be evaluated before and 30, 60, 180 minutes after a 20 meters air dive. Venous bubbles will be detected by precordial Doppler 30 minutes after the dive.\n\nIn association with this Doppler, Flow Mediated Dilation, blood samples analysing inflammatory and thrombotic factors and other biomarkers will be explored before and after the dive in order to know how vascular and respiratory tracts in this environment react.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be professional and voluntary diver\n* Man or woman aged 18 years or older\n* Diffusing Lung Capacity for Carbon Monoxide measured beforehand in the study\n* No medical contraindication for hyperbaric\n* No hyperbaric constraint in 3 days before the dive\n* No prior Decompression sickness\n* Not to follow medicinal treatment modifying the vascular endothelial and/or the coagulation and/or the respiratory function\n* Patient affiliated to social security\n* Informed and signed\n\nExclusion Criteria:\n\n* Concomitant pathology identified by the Investigator, justifying a contraindication for hyperbaric\n* Pregnant and nursing mothers\n* Patient who refuse to sign consent form'}, 'identificationModule': {'nctId': 'NCT02736006', 'acronym': 'DACODEC', 'briefTitle': 'Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks', 'orgStudyIdInfo': {'id': 'RB15.173 (DACODEC)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 meters air dive', 'interventionNames': ['Other: 20 meters air dive']}], 'interventions': [{'name': '20 meters air dive', 'type': 'OTHER', 'description': 'A dive in the depth of 20 m during 40 minutes. The divers will be evaluated before and 30, 60, 180 minutes after a 20 meters air dive. Venous bubbles will be detected by precordial Doppler 30 minutes after the dive.\n\nIn association with this Doppler, Flow Mediated Dilation, blood samples analysing inflammatory and thrombotic factors and other biomarkers will be explored before and after the dive in order to know how vascular and respiratory tracts in this environment react.', 'armGroupLabels': ['20 meters air dive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'country': 'France', 'facility': 'Brest, University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}