Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury
NCT ID: NCT05226858
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
56 participants
OBSERVATIONAL
2022-03-15
2025-12-31
Brief Summary
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Detailed Description
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Resuscitative 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.
Patients will be recruited into the study by investigators who take informed consent from the patient or next of kin prior to the TEE procedure.
For all patients with suspected BTAI, CTA is mandatory to confirm the diagnosis of BTAI.
TEE findings of BTAI will be compared to CTA which will be considered the reference standard unless confirmation is available from surgical procedures or autopsy.
Inter-observer variability for normal or pathological TEE images interpretation is performed prior to the initiation of the study.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Trauma patients with suspected blunt traumatic aortic injury (BTAI)
All trauma patients with suspected BTAI at the emergency department who require both transesophageal echocardiography (TEE) and computed tomography angiography (CTA).
Transesophageal echocardiography (TEE)
Sensitivity and specificity of TEE in identification of BTAI
Interventions
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Transesophageal echocardiography (TEE)
Sensitivity and specificity of TEE in identification of BTAI
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with contraindication to TEE such as suspected esophageal injury or pathology
18 Years
100 Years
ALL
No
Sponsors
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Hospital Sultanah Bahiyah
OTHER_GOV
Kuala Lumpur General Hospital
OTHER_GOV
Hospital Melaka
UNKNOWN
Hospital Queen Elizabeth, Malaysia
OTHER_GOV
University of Malaya
OTHER
Hospital Raja Permaisuri Bainun
OTHER_GOV
Responsible Party
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Dr. Adi Bin Osman
Principal Investigator
Principal Investigators
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Adi Osman, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Raja Permaisuri Bainun
Locations
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Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University of Malaya
Kuala Lumpur, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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NURUL LIANA ROSLAN
Role: primary
Role: backup
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NMRR-21-518-59250 (IIR)
Identifier Type: -
Identifier Source: org_study_id
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