Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

Recruiting

• Conditions: Trauma Chest
• Interventions: Diagnostic Test: Transesophageal echocardiography (TEE)

• Registration Number: NCT05226858
• Lead Sponsor: Hospital Raja Permaisuri Bainun

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.

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

All trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.

Exclusion Criteria

1. Children (age under 18 years) will not be eligible for inclusion in this study.
2. Patients with contraindication to TEE such as suspected esophageal injury or pathology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma patients with suspected blunt traumatic aortic injury (BTAI)	Transesophageal echocardiography (TEE)	All trauma patients with suspected BTAI at the emergency department who require both transesophageal echocardiography (TEE) and computed tomography angiography (CTA).

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of TEE in identification of BTAI	1 year	To determine the test performance of transesophageal echocardiography in the identification of BTAI in comparison to CTA.

Trial Locations

Locations (6)

Hospital Sultanah Bahiyah; 🇲🇾 Alor Setar, Kedah, Malaysia

Hospital Raja Permaisuri Bainun; 🇲🇾 Ipoh, Perak, Malaysia

Hospital Queen Elizabeth; 🇲🇾 Kota Kinabalu, Sabah, Malaysia

University of Malaya; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Melaka; 🇲🇾 Melaka, Malaysia