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NCT Number: NCT05226858

Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

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

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sultanah Bahiyah, Alor Star, Kedah, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transesophageal Echocardiography (TEE)

Diagnostic Test

Sensitivity and specificity of TEE in identification of BTAI

Primary outcomes

  1. Sensitivity and specificity of TEE in identification of BTAI

    Time frame: 1 year

    To determine the test performance of transesophageal echocardiography in the identification of BTAI in comparison to CTA.

Study contacts

Contact information is provided by the study sponsor or research team.

Adi Osman, MD

CONTACT

[email protected]

+6052087006

Pei Fong Chan, MBBS

CONTACT

[email protected]

+6052087009

Sponsors and collaborators

Lead sponsor

Hospital Raja Permaisuri Bainun

Other Gov

Collaborators

  • Hospital Melaka
  • Hospital Queen Elizabeth, Malaysia
  • Hospital Sultanah Bahiyah
  • Kuala Lumpur General Hospital
  • University of Malaya

Registry information

Official study title

Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2022
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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