Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination
Phase: NA
Conditions: Hemoperitoneum
Sponsor: The Guthrie Clinic

 
Protocol Date –10/05/2017 
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Study Protocol Title: 
 
Can we be FASTeR? A prospective study utilizing right sided roll to improve sensitivity of the 
FAST examination 
 
 
Principal Investigator, Research Team, and Study Site: 
 
Principal Investigator:  
Danielle Pigneri, MD 
 
Co-Investigators:  
 
Andrew A. Rosenthal, MD MBA 
                                                Stephanie Eyerly-Webb, PhD 
                              
 
Rachele Solomon, MPH  
 
Study Coordinator:  
 
Rachele Solomon, MPH 
 
 
 
 
 
Chief Research Officer:  
Candice Sareli, MD 
 
Study Address:  
            Memorial Regional Hospital 
3501 Johnson Street 
                        
 
Hollywood, FL 33021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents: 
 
Background Information and Scientific Rationale ........................................................................................ 4 
Summary of Previous Pre-clinical Studies/Relevant Clinical Studies .................................................. 4 
Potential Risks ...................................................................................................................................... 5 
Potential Benefits .................................................................................................................................. 5 
Study Objectives.......................................................................................................................................... 5 
Subject Selection ........................................................................................................................................... 6 
Inclusion Criteria ...................................................................................................................................... 6 
Exclusion Criteria ..................................................................................................................................... 6 
Study Procedures .......................................................................................................................................... 9 
Subject Identification, Recruitment, and Screening .................................................................................. 9 
Withdrawal of Subjects ............................................................................................................................. 9 
Quality Control and Quality Assurance ...................................................................................................... 10 
Ethical Considerations ................................................................................................................................ 10 
Confidentiality and Privacy .................................................................................................................... 10 
Conflict of Interest .................................................................................................................................. 10 
Funding Source ....................................................................................................................................... 11 
Publication Plan .......................................................................................................................................... 11 
References ................................................................................................................................................... 11 
 
 

 
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List of Abbreviations: 
FAST - Focused Assessment with Sonography in Trauma Exam  
ATLS - Acute Trauma Life Support 
FASTeR - FAST exam with Right sided roll 
CT - Computed Tomography  
PHI - Protected Health Information  
REDCap - Research Electronic Data Capture 
OR – Operating Room 
RUQ – Right Upper Quadrant 
LUQ – Left Upper Quadrant 
MRH – Memorial Regional Hospital 
MOI- Mechanism of Injury  
MRI – Magnetic Resonance Imaging 
ACS – American College of Surgeons 
 

 
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Introduction 
 
This document is a protocol for a human research study. This study is to be conducted 
according to US and international standards of Good Clinical Practice in accordance with 
applicable Federal regulations, International Conference on Harmonization guidelines, 
and institutional research policies and procedures.  
 
Background Information and Scientific Rationale 
 
Summary of Previous Pre-clinical Studies/Relevant Clinical Studies 
 
Rapid diagnosis and management of intra-abdominal hemorrhage after blunt trauma is 
critical in the triage and assessment of trauma patients (1). The Focused Assessment with 
Sonography in Trauma examination (FAST) is an efficient, bedside, non-ionizing, non-
invasive method for assessing hemoperitoneum (the presence of blood in the peritoneal 
cavity), in traumatically injured patients. The FAST is taught during the Acute Trauma 
Life Support (ATLS) Course, and is the gold standard for the initial assessment of 
abdominal and chest trauma (2). FASTs have excellent specificity (94.7-99.6% in most 
series), however sensitivity is low (20-60%) (3-5). Improving the sensitivity of the FAST 
would allow for earlier detection and management of life-threatening intra-abdominal 
hemorrhage for innumerable trauma patients. 
 
FASTs are typically performed with the patient in the standard position, lying flat on 
their back. The right upper quadrant (RUQ), left upper quadrant (LUQ) and suprapubic 
region are scanned and evaluated for hemoperitoneum. If fluid is found in any of these 
views, the patient is emergently taken to the operating room (OR) to treat the intra-
abdominal hemorrhage.  
     
It has been previously shown that a standard FAST is most likely to detect 
hemoperitoneum in the RUQ in Morison’s pouch, the space on the right side of the body 
that separates the liver and the right kidney (hepatorenal recess) (2). A recent pilot by 
Pigneri et al., compared standard FAST exam to FAST exam after the patient had been 
rolled onto their right side; this modified evaluation method was termed Focused 
Assessment with Sonography in Trauma examination after Right sided roll (FASTeR). 
The rationale was this position likely uses gravity to collect intra-abdominal fluid into 
Morison’s pouch, thus making it possible to visualize small volumes of fluid that would 
otherwise be undetectable when the patient is lying flat (6). This study demonstrated 
earlier identification of intra-abdominal fluid with the FASTeR when compared to the 
standard FAST (6).  
 
Rationale 
 
All patients are rolled onto one side or the other during normal trauma evaluation. 
Changing practice to turn the patient onto the right side for a modified FAST, or 
FASTeR, can potentially increase exam sensitivity without delaying care. Our goal is to 
perform a large, multicenter study to evaluate the impact of FASTeR versus the standard 

 
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FAST in hemodynamically unstable trauma patients. We plan to prospectively collect 
data for creation of a multicenter database; enrolled subjects would undergo both the 
standard FAST and when appropriate (see Methods) a FASTeR. Our aim is to determine 
the sensitivity and specificity of the FAST and FASTeR, and determine which exam was 
more accurate in recognizing hemoperitoneum. Exam results will be confirmed with 
computed tomography (CT) imaging or operative findings.  
 
 
Potential Risks and Benefits 
 
Potential Risks 
 
 
There are no expected medical risks to the study participants in excess of the normal risks 
of the FAST, which is minimal.  
 
Potential Benefits 
 
If the FASTeR is shown to detect small volumes of hemoperitoneum earlier than was 
previously possible with the FAST, patients may directly benefit from earlier diagnosis 
and treatment. Early identification of hemoperitoneum has been shown to be strongly 
correlated with increased survival rates (1). 
 
Study Objectives 
  
Primary Objective 
 
To calculate and compare the sensitivity and specificity of detecting hemoperitoneum in 
the RUQ for the standard FAST and the FASTeR in the research subjects. Actual injury 
complex will be confirmed by CT or operative findings. 
 
Secondary Objective 
 
To calculate and compare the false positive rate, false negative rate, positive predictive 
value, negative predictive value, and positive and negative likelihood ratios for the 
standard FAST and FASTeR. Exam results for individual subjects will be compared to 
see if there is a significant difference in result accuracy. 

 
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Study Design 
 
This is a prospective multicenter study.  Detailed responsibilities for the lead (Memorial 
Regional Hospital) and satellite centers below.   
 
Memorial Regional Hospital (lead)  
1. Maintain database for enrolled MRH subjects. Data collected will include HIPAA 
identifiers (included in outcome measures) to monitor our own data integrity.   
2. As lead center, MRH will aggregate and analyze collected data from satellite centers 
which will be submitted without HIPAA identifiers. 
3. MRH to manage subjects meeting inclusion criteria according to our institutional 
patient management protocols.  
4. MRH to adhere to IRB protocol and application as submitted.   
 
Satellite Centers 
1. Each center must apply and receive IRB approval from their respective IRB(s). 
2. Each center is responsible for their own data integrity, as outlined in their approved 
IRB protocol and application.     
3. Each center to provide IRB outcome or waiver letter to the lead center.  
4. Each center to complete the data sharing agreement specific to this study. 
5. Each center to provide care according to their institutional patient management 
protocols.  
6. Each center to submit de-identified data to the lead center for analysis. 
  
Subject Selection 
 
Inclusion Criteria 
1. Patients over 18 and under 89 years of age who present as a trauma 
activation with clinical history or physical signs of blunt abdominal 
trauma and hemodynamic instability 
 
Exclusion Criteria 
1.   Patients under 18 and over 89 years 
2. Pregnant women  
3. Patients with prohibitive right sided chest trauma 
4. Patients in extremis undergoing salvage maneuvers (chest compressions 
or emergent surgical intervention) which prevents performance of an 
ultrasound examination 
5. Patients who leave against medical advice or are otherwise removed from 
the medical system before their work up has been completed 
 
Sample Size 
 
50 participants at MRH and 250 participants total for all sites. 
 

 
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Research Design 
 
This is a prospective multicenter study, where MRH will act as the lead center.  Each 
contributing center is responsible for obtaining IRB approval and maintaining data 
integrity outlined in their approved IRB protocol and application from their respective 
institutions. Once IRB approval has been obtained, we will begin enrolling trauma 
patients prospectively into a registry. The participating centers for this study represent a 
diverse set of trauma centers and emergency departments and include institutions with 
varying trauma verifications (e.g. ACS and State), sizes, geographical/metropolitan 
locations, and resource availability to ensure inclusivity.  
 
Since this is a prospective observational study, data will be collected prospectively 
without altering the manner in which the patients are managed by the surgeon and 
institution. Accordingly, an informed consent waiver is requested. Patients will be given 
a flyer with information about the study (see additional documents). Data will be 
collected for a two year period with interim analysis when specific enrollment targets are 
met. All data will be recorded on a data sheet and transferred to a secured database 
(REDCap) without patient identifiers. 
 
Patients with clinical history or physical signs suspicious for blunt abdominal trauma will 
undergo the standard FAST in the emergency department as per ATLS protocol. During 
the secondary survey, all patients are rolled for examination of their back and removal of 
the rigid spine board, per ATLS. In our study, we will standardize this practice so that all 
patients are rolled onto their right side for this portion of the examination. Patients with 
extensive right sided chest trauma will be excluded at the discretion of the Trauma 
Surgeon. After the right sided roll to remove the back board, a repeat ultrasound 
examination of the RUQ will be performed.  
 
All participating centers, including MRH, will collect and submit the following data to 
the database for each enrolled subject: age, gender, initial trauma bay vital signs, 
mechanism of injury, results of the FAST, results of the FASTeR, and injury complex as 
confirmed by CT imaging or operative findings for their respective centers. Both the CT 
scan and any surgical intervention that the participant undergoes as a study subject will 
be performed through routine standard of care procedures. The database will not contain 
HIPAA identifiers. 
 
MRH will record our internal subject medical record numbers and dates of admission to 
verify data fields and monitor our own data integrity. All data will be de-identified prior 
to publication.  
 
 
Study Outcome Measures (Endpoints) 
 
The study outcome measures will be recorded using the “Multicenter Study: Can we be 
FASTeR? A multicenter study utilizing Right sided roll to improve sensitivity of the FAST 
examination” data collection form. The patient medical record number (MRN) will be 

 
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recorded by hand on the tool for all MRH enrolled subjects only; subject data will be 
cross-checked with the electronic records in order to maximize data integrity. 
 
1. Number of patients admitted and discharged from MRH between the timeframe 
(October 16, 2017- October 16, 2019) who present as a trauma activation with 
clinical history or physical signs of blunt abdominal trauma and hemodynamic 
instability 
a. MRN (recorded by hand), internal use only 
b. Admission date (recorded by hand), internal use only 
2. Demographics (e.g. age, gender) 
3. Admission vital signs (e.g. heart rate [bpm], blood pressure, respiratory rate, oxygen 
saturation) 
4. Results (positive or negative) of the FAST (RUQ, LUQ, surprapubic) 
5. Results of the FASTeR (RUQ) 
6. Method where final injury complex determined (if applicable) 
a. Operative findings  
b. CT scans  
c. Other imaging (e.g. MRI, x-ray, ultrasound) 
7. Final injury complex (if applicable)  
a. Liver injury 
b. Splenic injury 
c. Gastrointestinal injury (type)  
d. Genitourinary injury (type) 
e. Vascular/mesenteric injury (type) 
f. Pancreatic injury 
g. Other (type) 
8. Outcome of hemoperitoneum confirmed by imaging or operative findings  
 
 
Statistical Analysis Plan 
 
All subjects who meet inclusion criteria and have complete data available will be used for 
data analysis. The sensitivity and specificity (with confidence intervals) for detecting 
hemoperitoneum using the standard FAST or the FASTeR versus the actual injury 
complex findings (CT or operative findings) will be calculated in the research subjects 
along with the false positive rate, false negative rate, positive predictive value, negative 
predictive value, and positive and negative likelihood ratios. A McNemar’s test will be 
used to directly compare the accuracy of the FAST and FASTeR results for individual 
research subjects.  
 
The data pooled from the participating centers will provide a robust data set that will 
minimize center or physician specific result bias and provide the needed statistical 
volume as calculated by the power analysis. 
 
 

 
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Study Procedures 
 
Subject Identification, Recruitment, and Screening 
 
This a prospective multicenter study, which will prospectively record data without 
altering the manner in which the patients are managed by the surgeon and institution. 
Accordingly, an informed consent waiver is requested. All data will be recorded on a data 
sheet and transferred to a secured database (REDCap) without patient identifiers. 
 
Eligibility for study enrollment will be considered for all patients presenting to MRH as a 
trauma alert during the study period, with a clinical history or physical signs for blunt 
abdominal trauma who would clinically indicate a standard FAST in the  trauma bay as 
per ATLS protocol. Patients with extensive right sided chest trauma will be excluded at 
the discretion of the Trauma Surgeon. Both the CT scan and any surgical intervention 
that the participant undergoes as a study subject will be performed through routine 
standard of care procedures. 
 
Study Duration 
 
We anticipate a rolling accruement of subjects over a two year period.  A sample size 
calculation (power analysis) was performed to estimate the needed total participant 
accruement to provide a power of 90% and an alpha of <0.05. Standard FAST should 
identify up to 60% of subjects with significant intra-abdominal injury. If we assume that 
the FASTeR will identify hemoperitoneum in 1 of 4 subjects with intra-abdominal injury 
and previous negative FAST examination, then our needed sample size is 209 subjects. 
To account for subjects meeting exclusion criteria, we will plan to accrue 250 patients. 
Given that this sample size calculation was based on estimation regarding the sensitivity 
of the FASTeR in this patient population, interim analyses regarding primary endpoint 
will be conducted after 100 subjects have been accrued and again after 200 subjects have 
been accrued. Subject charts will be reviewed in increments of ten as they are enrolled.   
 
Withdrawal of Subjects 
 
Subjects that are unable to tolerate the position changes described in the protocol will be 
considered screening failures and will be automatically withdrawn from the study.  
 
Subjects that receive the FASTeR are free to withdraw themselves from the study at any 
time. They may withdraw from the study by notifying the PI, Dr. Pigneri, directly by 
phone. The option to withdraw and the contact information for Dr. Pigneri are listed on 
the study information flyer that will given to all subjects. 
 
 
 
 

 
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Quality Control and Quality Assurance 
 
Study data will be collected and managed using REDCap electronic data capture 
tools. REDCap (Research Electronic Data Capture) is a secure, web-based application 
designed to support data capture for research studies, providing 1) an intuitive interface 
for validated data entry; 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common 
statistical packages; and 4) procedures for importing data from external sources (7).  
 
Satellite centers are responsible for getting IRB approval and maintaining their own data 
integrity as outlined in their respective IRB protocols and applications.  The lead center 
(MRH) will aggregate and analyze deindentified data collected in REDCap.   
 
 
Ethical Considerations 
 
This study is to be conducted according to US and international standards of Good 
Clinical Practice, applicable government regulations and Institutional research policies 
and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal 
approval of the study conduct.   
 
Confidentiality and Privacy 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). Subjects may voluntarily withdraw from the program or revoke their 
authorization to share information related to the research. In the event that a subject 
revokes authorization to collect or use PHI, the investigator, by regulation, retains the 
ability to use all information collected prior to the revocation of subject authorization. 
 
Subjects will be assigned a study identification (ID) number that will distinguish subjects; 
a master code list linking the subject’s study ID to patient identifiers will not be shared 
and will be stored in a separate location from the study data. All data collected will be de-
identified and aggregated before sharing. The master code list and study data and will be 
destroyed following data analysis and study completion. All data will be de-identified 
prior to publication. 
 
Conflict of Interest 
 
There is no conflict of interest.  
 
 

 
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Funding Source 
 
None  
 
Publication Plan 
 
The Investigator intends to publish the results of this prospective study in a peer-
reviewed journal at an unspecified time in the future.  The Investigator will serve as the 
primary and corresponding author for any future publications related to this proposed 
study.   
 
References 
 
1. 
Barbosa RR, Rowell SE, Fox EE, Holcomb JB, Bulger EM, Phelan HA, et al. Increasing 
time to operation is associated with decreased survival in patients with a positive FAST exam 
requiring emergent laparotomy. The journal of trauma and acute care surgery. 2013;75(1 0 
1):S48. 
2. 
Rozycki GS, Ochsner MG, Feliciano DV, Thomas B, Boulanger BR, Davis FE, et al. 
Early detection of hemoperitoneum by ultrasound examination of the right upper quadrant: a 
multicenter study. Journal of Trauma and Acute Care Surgery. 1998;45(5):878-83. 
3. 
Fleming S, Bird R, Ratnasingham K, Sarker S-J, Walsh M, Patel B. Accuracy of FAST 
scan in blunt abdominal trauma in a major London trauma centre. International Journal of 
Surgery. 2012;10(9):470-4. 
4. 
Sheng AY, Dalziel P, Liteplo AS, Fagenholz P, Noble VE. Focused assessment with 
sonography in trauma and abdominal computed tomography utilization in adult trauma patients: 
trends over the last decade. Emergency medicine international. 2013;2013. 
5. 
Shojaee M, Faridaalaee G, Sabzghabaei A, Safari S, Mansoorifar H, Arhamidolatabadi A, 
et al. Sonographic detection of abdominal free fluid: emergency residents vs radiology residents. 
Trauma monthly. 2013;17(4):377. 
6. 
Pigneri DA GP. Can we be FASTeR? FAST examination after rolling to the Right 
dramatically increases sensitivity  
7. 
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. A metadata-driven 
methodology and workflow process for providing translational research informatics support. J 
Biomed Inform. 2009;42(2):377-81.