Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

Trauma Chest Clinical Trial

Official title:

Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226858
• Other study ID #: NMRR-21-518-59250 (IIR)
• Status: Recruiting
• Start date: March 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Hospital Raja Permaisuri Bainun
• Contact: Adi Osman, MD
• Phone: +6052087006
• Email: osman.adi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine test performance of transesophageal echocardiography performed by emergency physician ultrasound for the identification of blunt traumatic aortic injury in chest trauma.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Injuries
• Trauma Chest

Intervention

Diagnostic Test:
• Transesophageal echocardiography (TEE)
Sensitivity and specificity of TEE in identification of BTAI

Locations

Country	Name	City	State
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	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	Melaka

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Raja Permaisuri Bainun	Hospital Melaka, Hospital Queen Elizabeth, Malaysia, Hospital Sultanah Bahiyah, Kuala Lumpur General Hospital, University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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