Emergency Physician Performed Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury
Conditions: Trauma Chest
Sponsor: Hospital Raja Permaisuri Bainun

 
1 
 
 
 
Official Title of the study:  
Emergency Physician Performed Resuscitative Transesophageal Echocardiography (TEE) To 
Diagnose Blunt Traumatic Aortic Injury (BTAI) 
 
 
 
Date of Document:  
22rd February 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Title 
Emergency Physician Performed Resuscitative Transesophageal Echocardiography (TEE) To 
Diagnose Blunt Traumatic Aortic Injury (BTAI) 
Study type 
Multicentre prospective observational study 
Primary Investigator  
Dr. Adi Bin Osman 
Consultant Emergency Medicine 
Emergency and Trauma Department 
Hospital Raja Permaisuri Bainun 
Jalan Raja Ashman Shah, 30450 Ipoh, Perak. 
osman.adi@gmail.com 
Co-Investigator 
Dr. Chan Pei Fong 
Emergency Physician 
Emergency and Trauma Department 
Hospital Raja Permaisuri Bainun 
Jalan Raja Ashman Shah, 30450 Ipoh, Perak. 
chanpeifong@yahoo.com 
Dr. Azma Haryaty Ahmad,  
Emergency Physician  
Emergency and Trauma Department 
Hospital Raja Permaisuri Bainun 
Jalan Raja Ashman Shah, 30450 Ipoh, Perak. 
drazma78@yahoo.com.my 
Assoc. Prof. Dr. Shaik Farid Abdull Wahab 
Head of Department of Emergency Medicine,  
School of Medical Sciences, Health Campus, 
Universiti Sains Malaysia, 
16150 Kubang Kerian, Kelantan, Malaysia 
drsfarid@usm.my 
 
Dr. Roslanuddin bin Mohd Salehuddin 
Emergency and Trauma Department  
Hospital Sultanah Bahiyah, 
Km 6, Jalan Langgar, 05460, Alor Setar 
sledgy04@yahoo.com 
 
 
 

 
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Dr Sri Rao Siva  
Emergency & Trauma Department  
Hospital Kuala Lumpur  
Jalan Pahang, Wilayah Persekutuan 50586, Kuala Lumpur  
Malaysia  
sriraosiva@gmail.com 
 
Mohd Hafis B Mohamed Sakan 
Emergency and Trauma Department  
Hospital Melaka 
Jln Mufti Haji Khalil  
75400 Melaka 
hafissakan@gmail.com 
 
Muhammad Yusuf bin Muharam 
Emergency & Trauma Department 
Queen Elizabeth Hospital 
Karung Berkunci 2029, 
88586, Kota Kinabalu, Sabah. 
drmdyusuf@moh.gov.my 
 
Study Site 
1. Emergency and Trauma Department 
Hospital Raja Permaisuri Bainun, Ipoh, Perak. 
2. Department of Emergency Medicine, 
School of Medical Sciences, Health Campus, 
Universiti Sains Malaysia, Kelantan. 
 
3. Emergency and Trauma Department  
Hospital Sultanah Bahiyah, Alor Setar, Kedah 
 
4. Emergency & Trauma Department  
Hospital Kuala Lumpur, Kuala Lumpur. 
 
5. Emergency and Trauma Department  
Hospital Melaka, Melaka 
 
6. Emergency & Trauma Department 
Queen Elizabeth Hospital 
Kota Kinabalu, Sabah. 
 

 
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List of Abbreviations 
TEE 
transesophageal echocardiography 
BTAI 
blunt traumatic aortic injury 
ED 
emergency department 
CTA 
computed tomography angiography  
EFAST 
extended focused assessment with sonography for trauma 
TREE 
trauma resuscitation transesophagal echocardiography 
 
 
 
Research Synopsis 
Study title 
Emergency Physician Performed ResuscitativeTransesophageal 
Echocardiography (TEE) to Diagnose Blunt Traumatic Aortic Injury 
(BTAI) 
Study Population 
All trauma patients with suspected BTAI at the emergency 
department (ED) 
Study Design 
Multicentre prospective observational study 
Objective 
To determine test performance of resuscitative transesophageal 
echocardiography performed by emergency physician ultrasound for 
the identification of blunt traumatic aortic injury  
Study 
endpoints/outcomes 
Primary endpoints: Sensitivity and specificity of resuscitative TEE 
in identification of BTAI in comparison to CTA. 
Sample Size 
56 
Study Duration 
15-03-2022 until 15-3-2023 
 
 
 

 
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1. Background and Significance 
 
Blunt traumatic aortic injury (BTAI) is the second most common cause of death in 
blunt trauma with 80% of the patients dying at the scene (1, 2). The remaining survivors have 
an in-hospital of about 50% (2). It is thus important to diagnose BTAI as soon as possible to 
maximize the window of opportunity for definite treatment (3).  
Traditionally, invasive catheter aortography used to be the investigation of choice in 
diagnosing BTAI (4). With the introduction of helical computed tomography (CT) followed by 
CT angiography (CTA) in the 1990s (5), CT scan became the acceptable gold standard due to 
its high sensitivity of 96-100% and specificity of 95.0-99.8% (2,6).   
For patients who are hemodynamically unstable to be transported to CT suite, 
transesophageal echocardiography has been shown to be a reasonable alternative in 
identification of BTAI (7,8,9).  Similar to the use of transthoracic ultrasound in extended 
focused assessment with sonography for trauma (EFAST), trauma resuscitation transesophagal 
echocardiography (TREE) is a rapid bedside tool to assess the patient and guide potential 
therapy when transthoracic ultrasound is not possible (10,11). In fact, TEE has been proven to 
be more accurate in severe chest trauma compare to transthoracic echocardiography to pick up 
life-threatening injuries (12).  
Many studies had compared TEE with CT scan in the evaluation of aorta in the non-
trauma setting. CTA has been proven to be more superior to TEE to evaluate the atherosclerotic 
aorta in stroke (13). A meta-analysis in 2006 by Shiga et al showed that TEE and helical CT 
chest has similar positive likelihood ratio of 14.1 and 13.9 respectively in comparison to MRI 
(25.3) when diagnosing suspected thoracic aortic dissection (9).  
The accuracy of TEE and helical chest CT in diagnosing BTAI were validated against 
aortography separately in previous studies (7,9,14,15). Cinnella compared both imaging in an 
article review in 1998 in evaluating BTAI but did not find superiority in either helical chest CT 
or TEE (16). There was only one study which made a head-to- head comparison between 
helical chest CT with TEE in 2001 by Vignon et al in diagnosing BTAI. It was found that both 
modalities showed similar diagnostic accuracy with 100% specificity in diagnosing acute aortic 
injury (8). However, TEE was found to be more sensitive (93%) than helical chest CT (73%) 
in identifying thoracic aorta injuries especially intimal and medial lesions.  
To date, there is no study comparing CTA and TEE by emergency physicians to 
diagnose BTAI.  Here we will like to determine to test performance of resuscitative 
transesophageal echocardiography performed by emergency physician ultrasound for the 
identification of BTAI in chest trauma. 
2. Objective 
 
The objective of this study is to determine test performance of resuscitative transesophageal 
echocardiography performed by emergency physician ultrasound for the identification of 
blunt traumatic aortic injury. 

 
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Primary endpoints: Sensitivity and specificity of resuscitative TEE in identification of BTAI, 
in comparison to CTA. 
 
3. Methodology 
 
3.1 Study Type and Design 
 
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. 
 
Transesphageal Echocardiography 
Resuscitative TEE is performed in the emergency department by an emergency physician who 
had been trained in emergency ultrasound and advanced training in basic TEE examination. 
The TEE is performed with a Mindray M9 ultrasound machine via a multiplane probe (Mindray 
DC70, Shenzhen, China).  
 
Introduction of TEE probe is assisted with administration of intravenous fentanyl or 
midazolam, when necessary for sedation.  Application of lignocaine spray to the posterior 
pharynx is performed for the non-intubated patients. 
 
To specifically evaluate the aorta with suspected BTAI, we recommend using our department 
protocol-driven focused TEE exam. The exam is started by advancing the probe 30-40cm in a 
transverse plane (0-20°) to develop the mid-esophageal 4 chamber view (ME 4C). After 
centering the image on the left ventricle, and rotating the omniplane to 130° the mid-esophageal 
long axis (ME LAX) view is obtained, providing the first view of the ascending aorta. The 
aortic root can be visualized in this view and the proximal ascending aorta can be further 

 
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examined by withdrawing the TEE probe. After centering the image, the ascending aorta can 
be evaluated in both planes with the mid-esophageal ascending aorta short and long axis view 
(ME Asc Ao SAX and ME Asc Ao LAX) at 0° and 90° omniplane respectively.  
 
Following this, the focused was brought back to ME 4 chamber view, rotates the probe 
counterclockwise to the left and posteriorly from the perspective of the head, until the 
descending aorta comes to view. After reducing the image depth to magnify the image of the 
aorta, the descending thoracic aorta (DTA) is then visualized entirely by advancing the probe 
5-6 cm. By withdrawing the probe slowly, the aortic arch appears in a longitudinal view in the 
mid-esophageal DTA SAX view. The steps above are then repeated at 90° omniplane to obtain 
the ME DTA LAX view in the longitudinal plane. Finally, the aortic arch is evaluated 
throughout its visible length at the proximal part of the descending aorta using multiplane 
scanning. TEE images will be recorded. 
 
CT Angiography 
 
CT angiography is performed using 64 slices dual detector CT machine (Toshiba Aquilion CX 
2010, Japan). Findings of the CT scan is examined by a radiologist with more than 10 years 
experienced who is blinded to the TEE findings done beforehand. 
 
Data Collection & Image Analysis 
 
Injuries are assigned one of 4 grades of BTAI: grade 1 (intimal tear), grade II (intramural 
hematoma), grade III (pseudoaneurysm) and grade IV (rupture). 
 
The interpretation of TEE and CTA will be entered into the data collection form. The findings 
of the TEE by the emergency physicians will be compared with CTA images which are reported 
by the radiologist.  
 
3.2 Study Population 
All trauma patients with suspected BTAI in the emergency department (ED)  
 
3.3 Inclusion Criteria 
All trauma patients with suspected BTAI in the emergency department (ED). 
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). 
 
 

 
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3.4 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 
 
4.0 Withdrawal Criteria 
Subjects can choose to withdraw at any time. Subjects may be withdrawn if the investigator 
deems that it is detrimental or risky for the subject to continue. Withdrawn subjects will not be 
replaced. 
 
5.0 Study Duration and Timeline 
The study is expected to go on from 15-03-2022 until 15-3-2023 for 1 year. The data will be 
collected at the point of time during patient’s attendance at the emergency department. There 
will not be any follow up. 
 
6.0 Sample Size 
We calculate the sample size to determine whether resuscitative TEE is accurate to diagnose  
BTAI compare to CT scan as a gold standard.  
 
The null hypothesis is set as AUC 0.5 (meaning no discriminating power), Type 1 error of 
0.05 and power of 80%. Based on previous data (17), with a precision of 10%, and an 
expected proportion of BTAI on CTA of 10%, the sample size required was 45.  
 
Taking into account the potential for 20% incomplete data, we included 56 patients for the  
final analysis. AUROC sample size calculation was performed using an online statistic  
calculator. (https://www.scistat.com/samplesize/samplesize.php ) 
 
7.0 Statistical Analysis Plan 
 
Descriptive statistics will be applied to patient characteristics and diagnostic findings of the 
resuscitative TEE and CTA.  
 
The diagnostic performance of the TEE will be expressed as sensitivity (Se) and specificity 
(Sp), with their [confidence intervals at 95%]. Areas under receiver operating characteristic 
(ROC) curves will be compared for the correlation between ROC areas obtained from the two 
test modalities.  
 
Inter-rater reliability will be calculated with the Cohen’s kappa test.  Chance agreement is  
reflected by a kappa of 0, whereas a kappa of 1.0 constitutes perfect agreement. 
A p value < 0.05 is considered to indicate a statistically significant difference. 
 
Statistical analysis will be performed using the Statistical Package for the Social Sciences, 
version 20.0 (IBM, USA). 

 
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8.0 Risk and benefit to study participants 
Participation to the present study does not involve additional risk for the patient. The 
complications associated with TEE (bleeding, esophageal injury) and CTA (contrast allergy, 
worsening kidney function) are rare. Both investigations are part of the routine work up for 
chest trauma patients and the benefits outweigh the risks involved. 
 
The findings of the study will contribute to the evidence of the role of TEE in diagnosing BTAI 
for chest trauma patients in ED. 
 
9.0 Ethical Consideration 
The study will be conducted in accordance with the principles of Good Clinical Practice (ICH  
Harmonized Tripartite Guidelines for Good Clinical Practice 1996 Directive 91/507/EEC;D.M.  
15.7.1997), the Helsinki declaration and the international rules governing clinician  
experimentations worldwide. The participants, by signing this protocol, declare that they will  
fully conform to the described procedures and instructions. 
Approval has been obtained from the National Institutes of Health and the Medical Research 
and Ethics Committee, Ministry of Health Malaysia. 
 
 
10.0 Informed Consent 
Those patients meeting inclusion and exclusion criteria at the emergency department after the 
diagnosis of blunt throracic aortic injury (BTAI) is suspected, will be provided with   
information about the study.  
 
Specifically, research investigator will then explain to patient (or next of kin, if deemed 
necessary) that the patient will receive the usual diagnostic workup for BTAI. Written  
informed consent form will be provided together with the verbal explanation. 
 
The patient or next of kin will be allowed sufficient time to consider their participation in the 
study. If the patient or next of kin object to the inclusion of the patient in the study, their views 
will be respected. 
 
11.0 Privacy and Confidentiality 
All the information obtained in this study will be kept and handled in a confidential manner. 
No identifiers of the subjects will be captured by the data collection form. Subjects will be 
fully anonymized and a subject ID number will be assigned to each data collection form. 
Individuals involved in this study, qualified monitors, auditors and governmental or 
regulatory authorities may inspect the study data, where appropriate and necessary. The data 
captured via the data collection form will be entered into a computer that is password 
protected and analyzed using the aforementioned software installed in the computer.  

 
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On completion of study, data in the computer will be copied to CDs. Data in the computer 
will be erased. The informed consent forms, data collection forms and CDs will be stored 
under locked cabinets by the investigators and maintained for 3 years after the final 
publication and presentation. After 3 years, the data will be destroyed. The subjects may 
request for the results from the investigators at the end of the final write up if they are 
interested. 
12.0 Conflict of Interest 
The investigators declare they have no conflict of interest. 
13.0 Publication Policy 
The trial results will be published in an established peer-reviewed journal. No personal 
information of the subjects will be revealed during the publication process. Relevant 
permissions will be obtained prior to publication. 
14.0 Termination of Study 
The sponsor may decide to terminate the study at any time. Subjects will be informed if the 
study is terminated and follow-up visits will be arranged if needed. 
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