Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

NCT05226858 — Recruiting, 56 participants, Hospital Raja Permaisuri Bainun

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Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury

Registry	NCT05226858
Status	Recruiting
Study type	Observational
Enrollment	56 (Estimated)
Sponsor	Hospital Raja Permaisuri Bainun (Other gov); collaborators: Hospital Sultanah Bahiyah, Kuala Lumpur General Hospital, Hospital Melaka, Hospital Queen Elizabeth, Malaysia, University of Malaya
Conditions	Trauma Chest
Interventions	Transesophageal echocardiography (TEE) (Diagnostic test)
Dates	start 2022-03-15, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2022-02-07, last updated 2025-03-13
Locations	6 sites in Malaysia

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Trauma patients with suspected blunt traumatic aortic injury (BTAI)		Diagnostic Test: Transesophageal echocardiography (TEE)	All trauma patients with suspected BTAI at the emergency department who require both transesophageal echocardiography (TEE) and computed tomography angiography (CTA).

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

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to 100 Years

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

+Locations (6)

Facility	City	Country	Status
Hospital Sultanah Bahiyah	Alor Star, Kedah	Malaysia	Recruiting
Hospital Raja Permaisuri Bainun	Ipoh, Perak	Malaysia	Recruiting
Hospital Queen Elizabeth	Kota Kinabalu, Sabah	Malaysia	Terminated
Hospital Kuala Lumpur	Kuala Lumpur	Malaysia	Recruiting
University of Malaya	Kuala Lumpur	Malaysia	Recruiting
Hospital Melaka	Malacca	Malaysia	Recruiting

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2022-02-22)

+Investigators

Adi Osman, MD, Principal investigator, Hospital Raja Permaisuri Bainun