Trauma ChestNCT05226858
Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury
An observational study of Trauma Chest, run by Hospital Raja Permaisuri Bainun at 6 sites in Malaysia.
Trial summary
To determine test performance of transesophageal echocardiography performed by emergency physician ultrasound for the identification of blunt traumatic aortic injury in chest trauma. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trauma Chest
- What is being tested?
- Transesophageal echocardiography (TEE)
- How many people
- 56 participants
- Where
- 6 sitesMalaysia
- Study dates
- 15 Mar 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- All trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.
Who cannot join
- Children (age under 18 years) will not be eligible for inclusion in this study.
- Patients with contraindication to TEE such as suspected esophageal injury or pathology
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Malaysia6 sites, 5 recruiting
- Recruiting
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Roslanuddin Mohd Salehuddin, sledgy04@yahoo.com
Roslanuddin Mohd Salehuddin
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450
Adi Osman, osman.adi@gmail.com
Adi Osman
- Terminated
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, 88586
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, 50586
NURUL LIANA ROSLAN
drnurullianaroslan@gmail.com
- Recruiting
University of Malaya
Kuala Lumpur
Mohd Shahnaz Hasan, shahnaz@ummc.edu.my
- Recruiting
Hospital Melaka
Malacca, 75400
Mohd Hafis Mohamed Sakan, hafissakan@gmail.com
Mohd Hafis Mohamed Sakan
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma Chest
- Being tested
- Transesophageal echocardiography (TEE)
- Keywords
- Transesophageal echocardiography, Aorta, Trauma, Emergency department, Blunt Trauma
- Medical subject headings
- Thoracic Injuries, Wounds and Injuries, Emergencies, Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiography (TEE)Diagnostic test
Sensitivity and specificity of TEE in identification of BTAI
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Transesophageal echocardiography (TEE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Mar 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Raja Permaisuri Bainun
- Sponsor type
- Other government
- Collaborators
- Hospital Sultanah Bahiyah, Kuala Lumpur General Hospital, Hospital Melaka, Hospital Queen Elizabeth, Malaysia, University of Malaya
- Responsible party
- Principal investigator, Dr. Adi Bin Osman, Hospital Raja Permaisuri Bainun
- Investigators
- Adi Osman, MD, Principal investigator, Hospital Raja Permaisuri Bainun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226858
- Sponsor's protocol ID
- NMRR-21-518-59250 (IIR)
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury
- ClinicalTrials.gov ID
- NCT05226858
- Acronym / sponsor ID
- NMRR-21-518-59250 (IIR)
- Conditions
- Trauma Chest
- Keywords
- Transesophageal echocardiography, Aorta, Trauma, Emergency department, Blunt Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital Raja Permaisuri BainunOther government
- Collaborators
- Hospital Sultanah Bahiyah, Kuala Lumpur General Hospital, Hospital Melaka, Hospital Queen Elizabeth, Malaysia, University of Malaya
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- All trauma patients with suspected BTAI in the emergency department (ED) who undergo both TEE and CTA.
Key exclusion criteria (2 listed)
- Children (age under 18 years) will not be eligible for inclusion in this study.
- Patients with contraindication to TEE such as suspected esophageal injury or pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiography (TEE)Sensitivity and specificity of TEE in identification of BTAI | Diagnostic test | Trauma patients with suspected blunt traumatic aortic injury (BTAI) |
Primary outcome
Sensitivity and specificity of TEE in identification of BTAI
Time frame: 1 year
To determine the test performance of transesophageal echocardiography in the identification of BTAI in comparison to CTA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adi Osman, MD principal investigator
Hospital Raja Permaisuri Bainun
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Chest, run by Hospital Raja Permaisuri Bainun at 6 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adi Osman, MD (+6052087006, osman.adi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of TEE in identification of BTAI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.