Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury

Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt 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.

Study Overview

• Status: Recruiting
• Conditions: Trauma Chest
• Intervention / Treatment: Diagnostic test: Transesophageal echocardiography (TEE)

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.

• Study Type: Observational
• Enrollment (Estimated): 56

Contacts and Locations

• Study Contact: Name: Adi Osman, MD; Phone Number: +6052087006; Email: osman.adi@gmail.com
• Study Contact Backup: Name: Pei Fong Chan, MBBS; Phone Number: +6052087009; Email: chanpeifong12@gmail.com

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Recruiting
    • Hospital Kuala Lumpur
    • Contact: NURUL LIANA ROSLAN
    • Contact: Email: drnurullianaroslan@gmail.com
    • Principal Investigator: NURUL LIANA ROSLAN
  • Kuala Lumpur, Malaysia
    • Recruiting
    • University of Malaya
    • Contact: Mohd Shahnaz Hasan; Email: shahnaz@ummc.edu.my
  • Melaka, Malaysia, 75400
    • Recruiting
    • Hospital Melaka
    • Contact: Mohd Hafis Mohamed Sakan; Email: hafissakan@gmail.com
    • Principal Investigator: Mohd Hafis Mohamed Sakan
  • Kedah
    • Alor Setar, Kedah, Malaysia, 05460
      • Recruiting
      • Hospital Sultanah Bahiyah
      • Contact: Roslanuddin Mohd Salehuddin; Email: sledgy04@yahoo.com
      • Principal Investigator: Roslanuddin Mohd Salehuddin
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Recruiting
      • Hospital Raja Permaisuri Bainun
      • Contact: Adi Osman; Email: osman.adi@gmail.com
      • Principal Investigator: Adi Osman
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88586
      • Terminated
      • Hospital Queen Elizabeth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Diagnostic test: Transesophageal echocardiography (TEE); Sensitivity and specificity of TEE in identification of BTAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Raja Permaisuri Bainun
• Collaborators: University of Malaya; Hospital Queen Elizabeth, Malaysia; Kuala Lumpur General Hospital; Hospital Sultanah Bahiyah; Hospital Melaka
• Investigators: Principal Investigator: Adi Osman, MD, Hospital Raja Permaisuri Bainun

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Trauma; Emergency department; Aorta; Transesophageal echocardiography; Blunt Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries
• Other Study ID Numbers: NMRR-21-518-59250 (IIR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No