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:
Hospital Raja Permaisuri Bainun
Organization:
Study Overview
Official Title:
Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine test performance of transesophageal echocardiography performed by emergency physician ultrasound for the identification of blunt traumatic aortic injury in chest trauma.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: