Home » Trials » Trial #1620 » original TRDS
SLCTR Registration Number
SLCTR/2019/004
Date of Registration
The date of last modification
Mar 08, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Quality of the CT brain images at low radiation exposure compared to high radiation exposure among the patients who are indicated for non-contrast CT brain scan: A Non-inferiority Randomized single blind control trial
Public Title of Trial
Quality of the CT brain images at low radiation exposure compared to high radiation exposure.
Disease or Health Condition(s) Studied
Brain imaging
Scientific Acronym
None
Public Acronym
None
Brief title
Quality of the CT brain images at low radiation exposure compared to high radiation exposure among the patients
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P/122/06/2018 - Ethics Review Committee, Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
Are the quality of the CT brain images at low radiation exposure inferior to those with high radiation exposure?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Diagnostic
Study Phase
Not Applicable
Intervention(s) planned
Study setting Department of Radiology- CNTH-Ragama.
All eligible patients will be randomized to the intervention or control group using computer generated random numbers.
Intervention group patients will be exposed to tube current value of 125 milliamperes (Ma).
Control group will be exposed to manufacturer set default tube current value of 300 milliamperes (Ma) which is practiced currently.
A radiographer will carry out the CT examinations in control and study groups. Helical CT will be performed parallel to cantho-meatal line from skull base to vertex. Hard copy CT films will be printed for each patient to use image quality analysis.
Outcome assessors will be blinded to the intervention.
Inclusion criteria
• Patients of 18 years and above • Men and women • Patients who are sent the Radiology department for routine non contrast CT brain (Both traumatic and non traumatic).
Exclusion criteria
• Pregnant Patients
• Critically ill patients
• Unconscious patients
• Patients who are not able to provide information.
Primary outcome(s)
|
1.
Assessment of image quality in study group and control using European guide lines for quality criteria for CT http://www.drs.dk/guidelines/ct/quality/htmlindex.htm |
[ During routing CT reporting ] |
Secondary outcome(s)
|
1.
None |
[ N/A ] |
Target number/sample size
166 for each group.
Countries of recruitment
Sri Lanka
Anticipated start date
2019-02-01
Anticipated end date
2019-04-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2018-09-11
Approval number
P/122/06/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.C.Sirigampala
Consultant Radiologist.
Colombo North Teaching Hospital - Ragama
0112959261
0773772410
chandrasirigampala@gmail.com
Contact Person for Public Queries
Dr.C.Sirigampala
Consultant Radiologist.
Colombo North Teaching Hospital - Ragama
0112959261
0773772410
chandrasirigampala@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results will be shared after the de-identification (tables,figures,appendices). The study protocol will also be available. This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose. Data will be made available for IPD meta analysis.
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
