evaluation of the benefit of routine and selective chest CT scan in blunt chest trauma
Design
the clinical trial is performed on trauma patients, who are allocated to two parallel groups of selective and Routine. simple randomization is done based on a table of random numbers.
Settings and conduct
all the patients at the admission undergo basic imaging techniques including chest X-ray and eFast sonography. Patients in the Routine group undergoes the routine chest CT scan without contrast regardless of initial findings. patients in the selective group undergo a chest CT scan without contrast based on the positive findings in initial imaging and evaluation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: trauma patients who are transferred to Besat Hospital-Tehran
exclusion criteria: penetrating trauma, minor severity trauma, isolated limb trauma
Intervention groups
routine chest CT scan group
Main outcome variables
emergency department stay time, hospital stay time, ICU stay time, final outcome indicated therapeutic interventions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200505047307N2
Registration date:2020-10-18, 1399/07/27
Registration timing:retrospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Alireza Mirsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
alidiza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2019-09-06, 1398/06/15
Actual recruitment end date
2020-08-21, 1399/05/31
Trial completion date
2020-08-21, 1399/05/31
Scientific title
Comparison of results in outcome of routine and selective thoracic CT scan in conscious patients with moderate to severe blunt chest trauma
Public title
comparison of results in outcome ofroutine and selective chest CT scan in trauma patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
trauma patients who were transfered to Besat Hospital-Tehran
Exclusion criteria:
patients with undetectable vital signs, initially at the addmission
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
37
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was performed based on the table of random numbers. a specific point was chosen and numbers allocated to cases respectively from the top to the bottom of the table. patients with even numbers allocated to the Routine-CT scan group and patients with odd numbers allocated to the Selective-CT scan group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA university of Medical Sciences
Street address
Etemadzade st, Fatemi st.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.AJAUMS.REC.1398.146
Health conditions studied
1
Description of health condition studied
trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
hospital stay time
Timepoint
based on the patient`s discharge time
Method of measurement
based on the patient`s records
2
Description
therapeutic intervention
Timepoint
based on the course of treatment
Method of measurement
based on patient`s records
Secondary outcomes
1
Description
hospital stay time
Timepoint
based on the patient`s records
Method of measurement
based on the patient`s records
Intervention groups
1
Description
Intervention group: routine chest ct scan without contrast
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Alireza Mirsharifi
Street address
Takhti st. Basij hwy.
City
tehran
Province
Tehran
Postal code
11151 17819
Phone
+98 21 3995 5555
Email
shishegarmd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
alireza mirsharifi
Street address
etemad zadeh st., Fatemi st.
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
shishegarmd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Alireza Mirsharifi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
keshavarz blvd.
City
tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2450
Email
shariatihosp@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Mirsharifi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati Hospital, Jalal Ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alidiza@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Mirsharifi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shariati Hospital, Jalal Ale ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alidiza@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all data is publishable after deidentification
When the data will become available and for how long
unlimited availability
To whom data/document is available
eligible ones based on the publisher`s rules
Under which criteria data/document could be used
for scientific purposes with appropriate citation
From where data/document is obtainable
to the publisher/ corresponding author`s email address
What processes are involved for a request to access data/document
upon the request through the academic email addresses, data will be available