Pelvic CT Imaging in Blunt Abdominal Trauma

NCT ID: NCT01828749

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-03-31

Brief Summary

Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to identify a subset of low risk pediatric and adult patients in whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to significantly reduce utilization. The investigators propose an alternative and complimentary strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically important decrease in radiation exposure. The study will investigate this by comparing the accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.

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.

Conditions

Blunt Abdominal Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. 3-60 years of age evaluated for blunt trauma with a GCS of >14

2. Order of CT abdomen and pelvis imaging

Exclusion Criteria

1. Patients requiring intubation or suspected neurological injury (defined above)

2. Pregnant patients

3. Intoxicated patients

4. Patients with age defined hypotension

5. Exploratory laparotomy or transfusion during the ED evaluation

6. Non-verbal patients

7. Positive FAST exam

8. Patients with abdominal trauma or surgery in the last month

9. Victims of sexual assault or non-accidental trauma (NAT)

10. Patients with known or suspected fractures of the femur or pelvis prior to CT imaging

11. Patients with hip dislocations

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacy Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

02-13-19E

Identifier Type: -

Identifier Source: org_study_id