Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-02 @ 6:31 AM
Study NCT ID:
NCT03907150
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2019-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pneumothorax diagnosis by an inexperienced physician in lung ultrasound', 'timeFrame': 'May 1, 2021', 'description': 'The main endpoint will be a binary qualitative value: diagnosis of pneumothorax (yes/no) judged by inexperienced physicians performing pleural strain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pont-of-Care Ultrasound'], 'conditions': ['Pneumothorax']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.', 'detailedDescription': 'Prospective multi-centre diagnostic study based on the post-interpretation of recorded ultrasound loops as part of standard patient management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency Department or critical care patient who had a chest CT within 2 hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 17 years old\n* Management in an investigative centre\n* Presenting a suspicion of pneumothorax\n* Having had a pulmonary ultrasound scan\n* Having had a CT scan within 2 hours after or before the pulmonary ultrasound\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Persons not covered by a social security scheme\n* Persons deprived of their liberty\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under the protection of justice, guardianship or curatorship\n* Patient refuses to participate\n* It is impossible to give informed information about\n* The patient does not read French fluently\n* Patient with any known pulmonary pathology pre-existing prior to the hospitalization episode\n* Patient with a lung condition other than pneumothorax on a scanner'}, 'identificationModule': {'nctId': 'NCT03907150', 'briefTitle': 'Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study', 'orgStudyIdInfo': {'id': 'XBobbia/Pleurostrain'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pneumothorax', 'description': 'Pneumothorax', 'interventionNames': ['Diagnostic Test: Strain ultrasound']}, {'label': 'Normal', 'description': 'Normal lung', 'interventionNames': ['Diagnostic Test: Strain ultrasound']}], 'interventions': [{'name': 'Strain ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Post-interpretation of recorded ultrasound loops', 'armGroupLabels': ['Normal', 'Pneumothorax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM - Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Nimes University hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xavier Bobbia', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Nīmes'}}}}