Clinical trial NCT05226858: Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury
Official title: Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma Chest
Keywords: Transesophageal echocardiography
Aorta
Trauma
Emergency department
Blunt Trauma
Lead sponsor: Hospital Raja Permaisuri Bainun
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Sultanah Bahiyah
name: Kuala Lumpur General Hospital
name: Hospital Melaka
name: Hospital Queen Elizabeth, Malaysia
name: University of Malaya
First posted: 2022-02-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected BTAI are defined by the presence of at least one of the following criteria

1. high risk mechanism of injury (deceleration or crush injury),
2. clinical findings (external chest trauma or unexplained hypotension) or
3. chest Xray findings suspicious of BTAI (mediastinal widening, a blurred aortic knob, apical capping of the lung, a depressed left bronchus, a displaced nasogastric, mediastinal widening, or fractured first or second ribs).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of TEE in identification of BTAI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
state: Sabah
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
city: Melaka
country: Malaysia
facility: Hospital Melaka
Study officials:
affiliation: Hospital Raja Permaisuri Bainun
name: Adi Osman, MD
role: PRINCIPAL_INVESTIGATOR
References: