Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma (NCT01540318) | Clinical Trial Compass
CompletedNot Applicable
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
United States925 participantsStarted 2012-02
Plain-language summary
The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:
1. rate of abdominal CT scanning
2. time to emergency department disposition
3. the rate of missed/delayed diagnosis of intra-abdominal injury
4. the costs.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Blunt torso trauma resulting from a significant mechanism of injury
* Motor vehicle collision: greater than 60 mph, ejection, or rollover
* Automobile versus pedestrian/bicycle: automobile speed \> 25 mph
* Falls greater than 20 feet in height
* Crush injury to the torso
* Physical assault involving the abdomen
* Decreased level of consciousness (Glasgow Coma Scale score \< 15 or below age-appropriate behavior) in association with blunt torso trauma
* Blunt traumatic event with any of the following (regardless of the mechanism):
* Extremity paralysis
* Multiple long bone fractures (e.g., tibia and humerus fracture)
* History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
Exclusion Criteria:
* No concern for inter-abdominal injury or no planned evaluation for possible IAI
* Prehospital or ED age adjusted Hypotension
* Prehospital or initial ED GCS score ≤ 8
* Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
* Penetrating trauma: stab or gunshot wounds
* Traumatic injury occurring \> 24 hours prior to the time of presentation to the ED
* Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
* Patients with known dise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.