Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-03 @ 5:40 PM
Study NCT ID:
NCT04250532
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004332', 'term': 'Drowning'}], 'ancestors': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of abnormal pulse oximetry measure', 'timeFrame': '3 months after inclusion day', 'description': 'Quantify the number of subjects, whose pulse oximetry is measured as abnormal (superior to 94%) after immersion for 15 min in the ocean, in real condition.'}], 'secondaryOutcomes': [{'measure': 'Variation of pulse oximetry according to individuals factors', 'timeFrame': '3 months after inclusion day', 'description': 'Measures of immersion time, BMI before / after immersion.'}, {'measure': 'Variation of pulse oximetry according to environnementals factors', 'timeFrame': '3 months after inclusion day', 'description': 'Measures of air, water temperatures, felt air temperature, wet thermometer temperature, wind speed before / after immersion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drowning']}, 'descriptionModule': {'briefSummary': 'Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.', 'detailedDescription': 'The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic coast of Gironde, France, before and after their daily training, using a standardized measurement protocol.\n\nThe follow-up will be done during the beach monitoring period during the summer of 2020. A total of 3 months of measurement collection is expected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lifeguards working on the Girondine Atlantic coast', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lifeguard working on the Girondine Atlantic coast\n* up to 18 years old,\n* no smoker,\n* No chronic pathology.\n\nExclusion Criteria:\n\n* Chronic cardiac pathology,\n* Chronic respiratory pathology,\n* Acrosyndrome,\n* Smoker.'}, 'identificationModule': {'nctId': 'NCT04250532', 'acronym': 'POSEIDON', 'briefTitle': 'Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.', 'orgStudyIdInfo': {'id': 'CHUBX 2019/48'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lifeguard', 'description': 'Lifeguards who work on the Atlantic coast of Gironde France.', 'interventionNames': ['Other: Drowning']}], 'interventions': [{'name': 'Drowning', 'type': 'OTHER', 'description': 'Measurement of pulse oximetry, after lifeguard immersion during their morning training', 'armGroupLabels': ['Lifeguard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}