- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828749
Pelvic CT Imaging in Blunt Abdominal Trauma
Pelvic CT Imaging in Blunt Trauma: Limiting Low Yield Radiation Exposure in Carefully Selected Adult and Pediatric Patients
Study Overview
Status
Conditions
Detailed Description
Abdominopelvic computed tomography (CTap) utilization rose significantly in blunt trauma patients over the last decade but failed to reduce mortality or missed injury rates.
Primary Hypothesis: In stable, alert patients (GCS > 14) without clinically evident fractures of the pelvis, hip or lumbar spine, CT abdomen (CTa) alone (diaphragm to iliac crest) identifies intra-abdominal injury (IAI) with an accuracy that is not inferior to routine CTap (diaphragm to greater trochanter) with a clinically relevant reduction in radiation exposure.
Primary Aim: Compare the accuracy of CTa alone versus CTap to detect IAI in two age groups: ages 3-17 years and 18-60 years. Blunt trauma patients requiring CTap will be enrolled. Data obtained prior to CT imaging include demographics, injury mechanism, exam and pelvic radiograph findings and FAST results from the trauma evaluation. The original CTap will be digitally reformatted to create matched pairs of de-identified CTa and CTap studies. A board certified study radiologist, blinded to the original CT and clinical outcome, will interpret the CTa studies in injured patients. McNemar's chi-square test will be used to evaluate the null hypothesis for injuries in matched pairs assuming no difference for uninjured patients. Te the test characteristics of the CTa versus CTap will be determined. The reference standard will include initial radiology reports, operative reports, and 7-day medical record review. If the upper limit of the 95% confidence interval for the difference in the performance (accuracy) of CTap and CTa alone is less than 3%, the conclusion will be that CTa alone is not inferior to CTap to diagnose IAI. Secondary Aims: The mean effective doses of radiation will be calculated and compared with reductions up to 50% expected. The study will determine if physicians' pretest probability accurately identifies clinically significant pelvis, hip and lumbar spine fractures (CTp indications) in two age groups: ages 3-17 years and 18-60 years. Using a gestalt pretest probability of ≤ 2% as "negative for injury", and a pretest probability > 2% as "positive for injury", the test characteristics of physician estimation will be determined. The test characteristics and interobserver agreement (Cohen's kappa statistic) of exam findings expected to predict fractures of the pelvis, hip and lumbar spine will be reported separately.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28210
- Carolinas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 3-60 years of age evaluated for blunt trauma with a GCS of >14
- Order of CT abdomen and pelvis imaging
Exclusion Criteria:
- Patients requiring intubation or suspected neurological injury (defined above)
- Pregnant patients
- Intoxicated patients
- Patients with age defined hypotension
- Exploratory laparotomy or transfusion during the ED evaluation
- Non-verbal patients
- Positive FAST exam
- Patients with abdominal trauma or surgery in the last month
- Victims of sexual assault or non-accidental trauma (NAT)
- Patients with known or suspected fractures of the femur or pelvis prior to CT imaging
- Patients with hip dislocations
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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CT abdomen and pelvis
blunt trauma patients without suspected fractures of the pelvis, hip or lumbar spine in two age groups: ages 3-17 years and 18-60 years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intrabdominal Injury
Time Frame: 7 days
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Accuracy of CT abdomen alone versus CT abdomen and pelvis to detect IAI among stable, blunt trauma patients without suspected fractures of the pelvis, hip or lumbar spine will be compared.
The original abdominopelvic CT will be used to create matched pairs of de-identified and digitally reformatted CT abdomen and CT abdomen and pelvis studies.
A board certified study radiologist, blinded to the original CT reading and clinical outcome, will interpret the digitally reformatted CT abdomen studies in all injured patients.
McNemar's chi-square test will be used to evaluate the null hypothesis for the percentage of correctly identified injuries in the matched pairs assuming no difference for uninjured patients.
The sensitivity, specificity and accuracy of the CT abdomen alone versus CT abdomen and pelvis will be determined.
The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation Exposure
Time Frame: 7 days
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The radiation exposure for imaging protocols of the CT abdomen alone versus CT abdomen and pelvis for study patients in two age groups will be compared: ages 3-17 years and 18-60 years.
Using the reported volume CT dose index (CTDI vol), scan length and age specific coefficients for the abdomen/pelvis region of the body, the mean effective radiation doses for CT abdomen alone versus CT abdomen and pelvis will be calculated and compared.
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7 days
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physicians' pretest probability
Time Frame: 7 days
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Determine if physicians' pretest probability accurately identifies clinically significant pelvis, hip and lumbar spine fractures (clinical indications for CT pelvis) in study patients in two age groups: ages 3-17 years and 18-60 years.
Using a gestalt pretest probability of ≤ 2% as "negative for injury", and a pretest probability > 2% as "positive for injury", the test characteristics of physician estimation will be determined.
The test characteristics and interobserver agreement (Cohen's kappa statistic) of the physical examination findings known to predict fractures of the pelvis, hip and lumbar spine in alert, stable patients for each age group will be reported separately.
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7 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Stacy Reynolds, MD, Carolinas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-13-19E
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