FAST (Focussed Assessment With Sonography in Trauma)NCT04896463
Comparative Study of FAST Versus Multidetector CT Scan of the Abdomen in Patients With Abdominal Trauma
An observational study of FAST (Focussed Assessment With Sonography in Trauma), run by Assiut University.
Trial summary
The aim of the study is to evaluate the diagnostic accuracy of FAST (as regards sensitivity and specificity) as an initial assessment for patients with abdominal trauma compared to that of the gold standard multidetector CT scan of the abdomen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FAST (Focussed Assessment With Sonography in Trauma)
- What is being tested?
- Abdominal ultrasound (US)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: : The study will be conducted on patients admitted with abdominal trauma in Assuit or Alexandria Main University Hospitals after obtaining their or their next of kin consent to participate in the study without affecting their course of treatment according to permission obtained from ethical committee of faculty of medicine in Assiut and Alexandria universities.
Who may be able to join
- Adult patients (aged ≥18 years).
- Patients exposed to different mechanisms of abdominal trauma whether penetrating such as : stab or gunshot wounds . Or a blunt mechanism of trauma such as:motor vehicle collisions ,falls from height ,assaults ,falling down , falling a heavy object on torso , and sports accidents .
Who cannot join
- Pregnant females.
- Any patient who undergoes urgent surgical intervention as a primary survey.
- Patient refusal to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of FAST (Focussed Assessment With Sonography in Trauma) Versus Multidetector Computed Tomography (CT) Scan of the Abdomen in Patients With Abdominal Trauma
The aim of the study is to evaluate the diagnostic accuracy of FAST (as regards sensitivity and specificity) as an initial assessment for patients with abdominal trauma compared to that of the gold standard multidetector CT scan of the abdomen.
Read the detailed description
Trauma is a major health problem in every country, regardless of the level of socioeconomic development, associated with high morbidity and mortality as it is still the most frequent cause of death in the first four decades of life.According to the World Health Organization, more than nine people die per minute victimized by trauma, It is costy on the health services more than other diseases with a rate upto 12%.
In Egypt the mortality from road traffic crashes is about 12000 victims per year, with fatality rate of about 42 deaths per 100 000 population. Majority (48%) of them are passengers of motor vehicles. Car accidents in Egypt rose by 17.8% in 2019 with 9,992 compared to 8,480 in 2018 that is announced by The Central Agency For Public Mobilization and Statistics (CAPMAS).
The abdomen is the third most common injured region with surgery required in about 25% of civilian cases.
Abdominal trauma is traditionally classified as either blunt or penetrating (stab or gunshot wounds) which can usually be diagnosed easily and reliably, whereas blunt abdominal trauma is often missed because clinical signs are less obvious.Blunt abdominal injuries predominate in rural areas, while penetrating ones are more frequent in urban settings.
In order to minimize mortality in cases of abdominal trauma, risk factors for mortality needed to be systematically identified and studied. In recent years studies have identified a number of such risk factors, including sex, the length of the interval between abdominal injury and surgery, shock at the time of admission, and cranial injuries.
So appropriate care of the trauma patient entails a multidisciplinary effort that requires speed, efficiency,and proper coordination of the initial care team to make fast rational decisions.In such patient focussed abdominal ultrasonograpghy (FAST) often is the initial imaging examination.
FAST is readily available , low cost, repeatable noninvasive bedside method ,requires minimal preparation time ,and may be performed with mobile equipment that allows greater flexibility in patient positioning than is possible with other imaging modalities .It is also effective in depicting abnormally large intraperitoneal collections of free fluid, which are indirect evidence of a solid organ injury that requires emergency laparotomy.
However, not all clinically important abdominal injuries have associated hemoperitoneum such as those to the bowel , diaphragm, and mesentery. So an initial survey with FAST is often followed by a more thorough examination with multidetector computed tomography (CT) which became the imaging modality of choice in the late 1990s.It is a useful sen e method to detect intraperitoneal free air and intraperitoneal fluid,delineate the extent of solid organ injury,detect retroperitoneal injuries, and help in the decision of conservative nonsurgical therapy.But the adverse effects of it are that it is time consuming procedure and not advisable in hemodynamically unstable patients, moreover it is expensive and carries high risk of radiation exposure when repeated.
- Being tested
- Abdominal ultrasound (US)
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound (US)Radiation
Also called multidetector computed tomography (CT) scan of the abdomen
abdominal examination with US device
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence (positive FAST) or absence (negative FAST) of intraperitoneal free fluid collection in the four standard views to ascertain accuracy of FAST as regards sensitivity and specificity.
: FAST examination is performed using a mobile US machine with a curvilinear 3.5 to 5 -MHz probe while the patient in a recumbent position and the examiner stands to the right of the patient to obtain the following four standard views:
- Transverse view of the subxiphoid region to assess the pericardial space and injuries to the left lobe of the liver.
- Longituidinal view of the right upper quadrant (RUQ) to show the right lobe of the liver, the right kidney, the space between the two(the Morison pouch), and the right paracolic gutter.
- Longituidinal view of the left upper quadrant (LUQ) to show the left kidney, the spleen, the space between them, and the left para colic gutter.
- Transverse and longituidinal views of the suprapubic region to depict the urinary bladder and rectouterina or retrovesical pouch.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FAST (Focussed Assessment With Sonography in Trauma)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Salah El-Dein Quashty Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896463
- Sponsor's protocol ID
- FAST
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of FAST (Focussed Assessment With Sonography in Trauma) Versus Multidetector Computed Tomography (CT) Scan of the Abdomen in Patients With Abdominal Trauma
- ClinicalTrials.gov ID
- NCT04896463
- Acronym / sponsor ID
- FAST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 21 May 2021 (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.
The aim of the study is to evaluate the diagnostic accuracy of FAST (as regards sensitivity and specificity) as an initial assessment for patients with abdominal trauma compared to that of the gold standard multidetector CT scan of the abdomen.
Detailed description
Trauma is a major health problem in every country, regardless of the level of socioeconomic development, associated with high morbidity and mortality as it is still the most frequent cause of death in the first four decades of life.According to the World Health Organization, more than nine people die per minute victimized by trauma, It is costy on the health services more than other diseases with a rate upto 12%.
In Egypt the mortality from road traffic crashes is about 12000 victims per year, with fatality rate of about 42 deaths per 100 000 population. Majority (48%) of them are passengers of motor vehicles. Car accidents in Egypt rose by 17.8% in 2019 with 9,992 compared to 8,480 in 2018 that is announced by The Central Agency For Public Mobilization and Statistics (CAPMAS).
The abdomen is the third most common injured region with surgery required in about 25% of civilian cases.
Abdominal trauma is traditionally classified as either blunt or penetrating (stab or gunshot wounds) which can usually be diagnosed easily and reliably, whereas blunt abdominal trauma is often missed because clinical signs are less obvious.Blunt abdominal injuries predominate in rural areas, while penetrating ones are more frequent in urban settings.
In order to minimize mortality in cases of abdominal trauma, risk factors for mortality needed to be systematically identified and studied. In recent years studies have identified a number of such risk factors, including sex, the length of the interval between abdominal injury and surgery, shock at the time of admission, and cranial injuries.
So appropriate care of the trauma patient entails a multidisciplinary effort that requires speed, efficiency,and proper coordination of the initial care team to make fast rational decisions.In such patient focussed abdominal ultrasonograpghy (FAST) often is the initial imaging examination.
FAST is readily available , low cost, repeatable noninvasive bedside method ,requires minimal preparation time ,and may be performed with mobile equipment that allows greater flexibility in patient positioning than is possible with other imaging modalities .It is also effective in depicting abnormally large intraperitoneal collections of free fluid, which are indirect evidence of a solid organ injury that requires emergency laparotomy.
However, not all clinically important abdominal injuries have associated hemoperitoneum such as those to the bowel , diaphragm, and mesentery. So an initial survey with FAST is often followed by a more thorough examination with multidetector computed tomography (CT) which became the imaging modality of choice in the late 1990s.It is a useful sen e method to detect intraperitoneal free air and intraperitoneal fluid,delineate the extent of solid organ injury,detect retroperitoneal injuries, and help in the decision of conservative nonsurgical therapy.But the adverse effects of it are that it is time consuming procedure and not advisable in hemodynamically unstable patients, moreover it is expensive and carries high risk of radiation exposure when repeated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- : The study will be conducted on patients admitted with abdominal trauma in Assuit or Alexandria Main University Hospitals after obtaining their or their next of kin consent to participate in the study without affecting their course of treatment according to permission obtained from ethical committee of faculty of medicine in Assiut and Alexandria universities.
Key inclusion criteria (2 listed)
- Adult patients (aged ≥18 years).
- Patients exposed to different mechanisms of abdominal trauma whether penetrating such as : stab or gunshot wounds . Or a blunt mechanism of trauma such as:motor vehicle collisions ,falls from height ,assaults ,falling down , falling a heavy object on torso , and sports accidents .
Key exclusion criteria (3 listed)
- Pregnant females.
- Any patient who undergoes urgent surgical intervention as a primary survey.
- Patient refusal to participate.
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 |
|---|---|---|
| Abdominal ultrasound (US)Also: multidetector computed tomography (CT) scan of the abdomenabdominal examination with US device | Radiation | – |
Primary outcome
The presence (positive FAST) or absence (negative FAST) of intraperitoneal free fluid collection in the four standard views to ascertain accuracy of FAST as regards sensitivity and specificity.
Time frame: baseline
: FAST examination is performed using a mobile US machine with a curvilinear 3.5 to 5 -MHz probe while the patient in a recumbent position and the examiner stands to the right of the patient to obtain the following four standard views: * Transverse view of the subxiphoid region to assess the pericardial space and injuries to the left lobe of the liver. * Longituidinal view of the right upper quadrant (RUQ) to show the right lobe of the liver, the right kidney, the space between the two(the Morison pouch), and the right paracolic gutter. * Longituidinal view of the left upper quadrant (LUQ) to show the left kidney, the spleen, the space between them, and the left para colic gutter. * Transverse and longituidinal views of the suprapubic region to depict the urinary bladder and rectouterina or retrovesical pouch.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of FAST (Focussed Assessment With Sonography in Trauma), run by Assiut University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeinab Salah (00201143751762, zeinabsalah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence (positive FAST) or absence (negative FAST) of intraperitoneal free fluid collection in the four standard views to ascertain accuracy of FAST as regards sensitivity and specificity. (time frame: baseline). 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 21 May 2021.