Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

NCT ID: NCT05226858

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Trauma Chest

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Transesophageal echocardiography (TEE)

Intervention Type DIAGNOSTIC_TEST

Sensitivity and specificity of TEE in identification of BTAI

Interventions

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Transesophageal echocardiography (TEE)

Sensitivity and specificity of TEE in identification of BTAI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sultanah Bahiyah

OTHER_GOV

Sponsor Role collaborator

Kuala Lumpur General Hospital

OTHER_GOV

Sponsor Role collaborator

Hospital Melaka

UNKNOWN

Sponsor Role collaborator

Hospital Queen Elizabeth, Malaysia

OTHER_GOV

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role collaborator

Hospital Raja Permaisuri Bainun

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Adi Bin Osman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adi Osman, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Raja Permaisuri Bainun

Locations

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Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Site Status RECRUITING

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Site Status RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, Malaysia

Site Status TERMINATED

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status RECRUITING

University of Malaya

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Hospital Melaka

Malacca, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Adi Osman, MD

Role: CONTACT

+6052087006

Pei Fong Chan, MBBS

Role: CONTACT

+6052087009

Facility Contacts

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Roslanuddin Mohd Salehuddin

Role: primary

Adi Osman

Role: primary

NURUL LIANA ROSLAN

Role: primary

Role: backup

Mohd Shahnaz Hasan

Role: primary

Mohd Hafis Mohamed Sakan

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NMRR-21-518-59250 (IIR)

Identifier Type: -

Identifier Source: org_study_id

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