Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 10:53 PM
Study NCT ID:
NCT05617404
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2022-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blunt Thoracic Trauma: Definition of a Standard Operating Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012253', 'term': 'Rib Fractures'}, {'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best predictor of respiratory complications', 'timeFrame': '01/02/2021 - 18/08/2022', 'description': 'Compare different items to identify the best predictor of respiratory complications: resipratory failure and pneumonia.'}], 'secondaryOutcomes': [{'measure': 'Compare XRay and CT', 'timeFrame': '01/02/2021 - 18/08/2022', 'description': 'Compare findings in x-ray (read by surgeon), x-ray (read by radiologist) and CT scan'}, {'measure': 'Number of fractures to predict complications', 'timeFrame': '01/02/2021 - 18/08/2022', 'description': 'Analyse if there is a number of rib fracture that can predict respiratory complications'}, {'measure': 'Compare scores', 'timeFrame': '01/02/2021 - 18/08/2022', 'description': 'Compare different scores: OIS, CTS, Ribscore, Rib Fracture Score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rib Fractures', 'Polytrauma', 'Thoracic Injury', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge.\n\nThis study analyses the correlation between chest X-Ray and CT scan. We also analyse different scores to predict respiratory failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We included all patients older than 18 years old admitted to our hospital due to a polytrauma that were admitted to the ICU and had a CT scan in the first 24 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polytrauma patients admitted to de ICU with a thoracic CT scan in the first 24h of arrival\n\nExclusion Criteria:\n\n* Penetrating trauma\n* Patients referred from other hospitals'}, 'identificationModule': {'nctId': 'NCT05617404', 'briefTitle': 'Blunt Thoracic Trauma: Definition of a Standard Operating Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Blunt Thoracic Trauma: Definition of a Standard Operating Procedure', 'orgStudyIdInfo': {'id': 'CGHUPTRGR01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Polytrauma patients with thoracic CT-scan'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sabadell', 'country': 'Spain', 'facility': 'Hospital Universitari Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon', 'investigatorFullName': 'Raquel Gracia-Roman', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}