NCT05226858

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

January 4, 2022

Last Update Submit

March 12, 2025

Conditions

Keywords

Transesophageal echocardiographyAortaTraumaEmergency departmentBlunt Trauma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)

Interventions

Sensitivity and specificity of TEE in identification of BTAI

Trauma patients with suspected blunt traumatic aortic injury (BTAI)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • All trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.

You may not qualify if:

  • Patients with contraindication to TEE such as suspected esophageal injury or pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

RECRUITING

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88586, Malaysia

TERMINATED

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

RECRUITING

University of Malaya

Kuala Lumpur, Malaysia

RECRUITING

Hospital Melaka

Malacca, 75400, Malaysia

RECRUITING

MeSH Terms

Conditions

Thoracic InjuriesWounds and InjuriesEmergenciesWounds, Nonpenetrating

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Adi Osman, MD

    Hospital Raja Permaisuri Bainun

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Osman, MD

CONTACT

Pei Fong Chan, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 7, 2022

Study Start

March 15, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations