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| Name | Class |
|---|---|
| Hospital Sultanah Bahiyah | OTHER_GOV |
| Kuala Lumpur General Hospital | OTHER_GOV |
| Hospital Melaka | UNKNOWN |
| Hospital Queen Elizabeth, Malaysia |
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To determine test performance of transesophageal echocardiography performed by emergency physician ultrasound for the identification of blunt traumatic aortic injury in chest trauma.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transesophageal echocardiography (TEE) | Diagnostic Test | Sensitivity and specificity of TEE in identification of BTAI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of TEE in identification of BTAI | To determine the test performance of transesophageal echocardiography in the identification of BTAI in comparison to CTA. | 1 year |
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Inclusion Criteria:
All trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.
Exclusion Criteria:
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Suspected BTAI are defined by the presence of at least one of the following criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adi Osman, MD | Contact | +6052087006 | osman.adi@gmail.com | |
| Pei Fong Chan, MBBS | Contact | +6052087009 | chanpeifong12@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adi Osman, MD | Hospital Raja Permaisuri Bainun | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultanah Bahiyah | Recruiting | Alor Star | Kedah | 05460 | Malaysia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2022 | Feb 23, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
| D004630 | Emergencies |
| D014949 | Wounds, Nonpenetrating |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017548 | Echocardiography, Transesophageal |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| OTHER_GOV |
| University of Malaya | OTHER |
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| Hospital Raja Permaisuri Bainun | Recruiting | Ipoh | Perak | 30450 | Malaysia |
|
| Hospital Queen Elizabeth | Terminated | Kota Kinabalu | Sabah | 88586 | Malaysia |
| Hospital Kuala Lumpur | Recruiting | Kuala Lumpur | 50586 | Malaysia |
|
| University of Malaya | Recruiting | Kuala Lumpur | Malaysia |
|
| Hospital Melaka | Recruiting | Malacca | 75400 | Malaysia |
|
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |