Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 5:08 AM
Study NCT ID:
NCT04912206
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-30', 'releaseDate': '2024-04-04'}, {'resetDate': '2024-11-20', 'releaseDate': '2024-09-19'}, {'resetDate': '2025-01-08', 'releaseDate': '2024-11-22'}, {'resetDate': '2025-02-13', 'releaseDate': '2025-02-13'}], 'estimatedResultsFirstSubmitDate': '2024-04-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-05-28', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exact diagnostic rate', 'timeFrame': "The reference diagnosis will be determined by an adjudication committee on the basis of an exhaustive analysis of the patient's file at Day 28", 'description': 'Comparison of the rate of exact diagnostic after clinical exam and biological results with point-of-care ultrasound (interventional arm) or without (control arm) according to the adjudication committee diagnostic (reference diagnosis).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal Pain', 'Point-of-Care Ultrasound'], 'conditions': ['Abdominal Pain']}, 'referencesModule': {'references': [{'pmid': '38409086', 'type': 'DERIVED', 'citation': 'Brau F, Papin M, Batard E, Abet E, Frampas E, Le Thuaut A, Montassier E, Le Bastard Q, Le Conte P. Impact of emergency physician performed ultrasound in the evaluation of adult patients with acute abdominal pain: a prospective randomized bicentric trial. Scand J Trauma Resusc Emerg Med. 2024 Feb 26;32(1):15. doi: 10.1186/s13049-024-01182-5.'}, {'pmid': '36153600', 'type': 'DERIVED', 'citation': 'Brau F, Martin S, Le Bastard Q, Ricaud P, Legrand A, Montassier E, Le Conte P. Impact of emergency physician-performed ultrasound for the evaluation of patients with acute abdominal pain, prospective randomized dual Centre study: study protocol for a diagnostic trial. Trials. 2022 Sep 24;23(1):804. doi: 10.1186/s13063-022-06755-2.'}]}, 'descriptionModule': {'briefSummary': "Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain. However, the level of evidence of its diagnostic efficacy remains controversial in particular in Europe.\n\nThe principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two emergency departments (ED). Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.", 'detailedDescription': "Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain.\n\nThe principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two ED. Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.\n\nIt will be a randomized, controlled, open and interventional study. In the control group, the diagnosis will be established after clinical examination and reception of biological analysis results. In the interventional group, a POCUS performed in the ED by a local investigator will be added and the diagnosis will be established after clinical exam, biological analysis reception and POCUS. POCUS will only be performed by physicians who have completed a validated training program.\n\nFurthermore, before study initiation, refresh sessions focused on acquisition techniques and pathological findings will be organized in the two participating ED. Such refresher courses were efficient to increase the overall confidence of operators"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Admitted for acute abdominal pain lasting for less than 5 days\n* Availability in the ED at that time of an Emergency Physician trained in POCUS\n* Patient able to understand the protocol and having given oral informed consent to participate in the study or included under the emergency inclusion procedure\n\nExclusion Criteria:\n\n* Documented end-of-life with a do-not-resuscitate order\n* Immediate need for management for hemodynamic stabilization\n* Patient sent to the ED by an out-of-hospital practitioner\n* Pregnant and breast-feeding women\n* No social security\n* Under guardianship, curatorship or deprived of liberty.\n* Do not understand French'}, 'identificationModule': {'nctId': 'NCT04912206', 'acronym': 'EchoPAIN', 'briefTitle': 'Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study', 'orgStudyIdInfo': {'id': 'CHD20_0133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Point-of-Care Ultrasound on top of diagnosis work-up', 'interventionNames': ['Diagnostic Test: Point-of-Care Ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual diagnosis work-up without Point-of-Care Ultrasound'}], 'interventions': [{'name': 'Point-of-Care Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Abdominal clinician-performed Ultrasound', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Departemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'François Brau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHD Vendée'}, {'name': 'Philippe Leconte', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-04', 'type': 'RELEASE'}, {'date': '2024-08-30', 'type': 'RESET'}, {'date': '2024-09-19', 'type': 'RELEASE'}, {'date': '2024-11-20', 'type': 'RESET'}, {'date': '2024-11-22', 'type': 'RELEASE'}, {'date': '2025-01-08', 'type': 'RESET'}, {'date': '2025-02-13', 'type': 'RELEASE'}, {'date': '2025-02-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Centre Hospitalier Departemental Vendee'}}}}