Pelvic CT Imaging in Blunt Abdominal Trauma

NCT01828749 | Completed

• 1 other identifier: 02-13-19E
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Blunt Abdominal Trauma

Keywords

blunt abdominal trauma; CT; radiation exposure, pediatric

Outcome Measures

Primary Outcomes (1)

• Intrabdominal Injury

  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.

  7 days

Secondary Outcomes (2)

• Radiation Exposure

  7 days

• physicians' pretest probability

  7 days

Study Arms (1)

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

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

3-60 years of age evaluated for blunt trauma with a GCS of \>14 Order of CT abdomen and pelvis imaging

You may qualify if:

• years of age evaluated for blunt trauma with a GCS of \>14
• Order of CT abdomen and pelvis imaging

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28210, United States

Location

Study Officials

• Stacy Reynolds, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: April 11, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2015
• Last Updated: April 25, 2022

Record last verified: 2015-12

Locations

US (1)