Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

Sponsor

Hospital Raja Permaisuri Bainun (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05226858

Collaborator

Universiti Sains Malaysia (Other), Hospital Sultanah Bahiyah (Other), Kuala Lumpur General Hospital (Other), Hospital Melaka (Other), Hospital Queen Elizabeth, Malaysia (Other)

Enrollment

Locations

14.6

Anticipated Duration (Months)

9.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Chest	Diagnostic Test: Transesophageal echocardiography (TEE)

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 Design

Study Type:

Observational

Anticipated Enrollment :

56 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury

Anticipated Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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).	Diagnostic Test: Transesophageal echocardiography (TEE) Sensitivity and specificity of TEE in identification of BTAI

Arm

Intervention/Treatment

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).

Diagnostic Test: Transesophageal echocardiography (TEE)

Sensitivity and specificity of TEE in identification of BTAI

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Sultanah Bahiyah	Alor Setar	Kedah	Malaysia	05460
2	School of Medical Sciences, Health Campus, Universiti Sains Malaysia	Kubang Kerian	Kelantan	Malaysia	16150
3	Hospital Raja Permaisuri Bainun	Ipoh	Perak	Malaysia	30450
4	Hospital Queen Elizabeth	Kota Kinabalu	Sabah	Malaysia	88586
5	Hospital Kuala Lumpur	Kuala Lumpur		Malaysia	50586
6	Hospital Melaka	Melaka		Malaysia	75400