Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 12:31 PM
Study NCT ID:
NCT05226858
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017548', 'term': 'Echocardiography, Transesophageal'}], 'ancestors': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-22', 'size': 388154, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-23T09:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of TEE in identification of BTAI', 'timeFrame': '1 year', 'description': 'To determine the test performance of transesophageal echocardiography in the identification of BTAI in comparison to CTA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transesophageal echocardiography', 'Aorta', 'Trauma', 'Emergency department', 'Blunt Trauma'], 'conditions': ['Trauma Chest']}, 'descriptionModule': {'briefSummary': 'To determine test performance of transesophageal echocardiography performed by emergency physician ultrasound for the identification of blunt traumatic aortic injury in chest trauma.', 'detailedDescription': 'This is a multicentre prospective observational trial. All trauma patients with suspected BTAI at the emergency department (ED) will undergo resuscitative transesophageal echocardiography to evaluate the thoracic aorta.\n\nResuscitative TEE is a minimally invasive procedure to evaluate all chest trauma patients. Besides the aorta, TEE can also provide other useful information regarding the hemodynamic status, cardiac function and lung pathology of the patient.\n\nPatients will be recruited into the study by investigators who take informed consent from the patient or next of kin prior to the TEE procedure.\n\nFor all patients with suspected BTAI, CTA is mandatory to confirm the diagnosis of BTAI.\n\nTEE findings of BTAI will be compared to CTA which will be considered the reference standard unless confirmation is available from surgical procedures or autopsy.\n\nInter-observer variability for normal or pathological TEE images interpretation is performed prior to the initiation of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Suspected BTAI are defined by the presence of at least one of the following criteria\n\n1. high risk mechanism of injury (deceleration or crush injury),\n2. clinical findings (external chest trauma or unexplained hypotension) or\n3. chest Xray findings suspicious of BTAI (mediastinal widening, a blurred aortic knob, apical capping of the lung, a depressed left bronchus, a displaced nasogastric, mediastinal widening, or fractured first or second ribs).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.\n\nExclusion Criteria:\n\n1. Children (age under 18 years) will not be eligible for inclusion in this study.\n2. Patients with contraindication to TEE such as suspected esophageal injury or pathology'}, 'identificationModule': {'nctId': 'NCT05226858', 'briefTitle': 'Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Raja Permaisuri Bainun'}, 'officialTitle': 'Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury', 'orgStudyIdInfo': {'id': 'NMRR-21-518-59250 (IIR)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trauma patients with suspected blunt traumatic aortic injury (BTAI)', 'description': 'All trauma patients with suspected BTAI at the emergency department who require both transesophageal echocardiography (TEE) and computed tomography angiography (CTA).', 'interventionNames': ['Diagnostic Test: Transesophageal echocardiography (TEE)']}], 'interventions': [{'name': 'Transesophageal echocardiography (TEE)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sensitivity and specificity of TEE in identification of BTAI', 'armGroupLabels': ['Trauma patients with suspected blunt traumatic aortic injury (BTAI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05460', 'city': 'Alor Star', 'state': 'Kedah', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Roslanuddin Mohd Salehuddin', 'role': 'CONTACT', 'email': 'sledgy04@yahoo.com'}, {'name': 'Roslanuddin Mohd Salehuddin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sultanah Bahiyah', 'geoPoint': {'lat': 6.12104, 'lon': 100.36014}}, {'zip': '30450', 'city': 'Ipoh', 'state': 'Perak', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Adi Osman', 'role': 'CONTACT', 'email': 'osman.adi@gmail.com'}, {'name': 'Adi Osman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Raja Permaisuri Bainun', 'geoPoint': {'lat': 4.5841, 'lon': 101.0829}}, {'zip': '88586', 'city': 'Kota Kinabalu', 'state': 'Sabah', 'status': 'TERMINATED', 'country': 'Malaysia', 'facility': 'Hospital Queen Elizabeth', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'zip': '50586', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'NURUL LIANA ROSLAN', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'drnurullianaroslan@gmail.com'}, {'name': 'NURUL LIANA ROSLAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Kuala Lumpur', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Mohd Shahnaz Hasan', 'role': 'CONTACT', 'email': 'shahnaz@ummc.edu.my'}], 'facility': 'University of Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '75400', 'city': 'Malacca', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Mohd Hafis Mohamed Sakan', 'role': 'CONTACT', 'email': 'hafissakan@gmail.com'}, {'name': 'Mohd Hafis Mohamed Sakan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Melaka', 'geoPoint': {'lat': 2.196, 'lon': 102.2405}}], 'centralContacts': [{'name': 'Adi Osman, MD', 'role': 'CONTACT', 'email': 'osman.adi@gmail.com', 'phone': '+6052087006'}, {'name': 'Pei Fong Chan, MBBS', 'role': 'CONTACT', 'email': 'chanpeifong12@gmail.com', 'phone': '+6052087009'}], 'overallOfficials': [{'name': 'Adi Osman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Raja Permaisuri Bainun'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Raja Permaisuri Bainun', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hospital Sultanah Bahiyah', 'class': 'OTHER_GOV'}, {'name': 'Kuala Lumpur General Hospital', 'class': 'OTHER_GOV'}, {'name': 'Hospital Melaka', 'class': 'UNKNOWN'}, {'name': 'Hospital Queen Elizabeth, Malaysia', 'class': 'OTHER_GOV'}, {'name': 'University of Malaya', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Adi Bin Osman', 'investigatorAffiliation': 'Hospital Raja Permaisuri Bainun'}}}}