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NCT01341015 · ClinicalTrials.gov registry record · Early Phase 1
Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
A Early Phase 1 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT01341015 is a Early Phase 1 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 50 participants.
The verdict
NCT01341015, a Early Phase 1 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Objectives: A lot of children who injure their ankles come to the emergency department for an evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency departments are time consuming, often uncomfortable for the patient, and expose children to radiation, the long-term effects of which are not yet fully understand by doctors or scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not produce radiation. It was been shown to determine the presence of bone fracture in childrens' wrists and forearms just as well as X-rays do. In our study, the investigators would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures in children. Research Procedures: In our study, the investigators will ask the parents and children, who are scheduled to get an X-ray of their ankle in the emergency department, to examine their ankles with an ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming, does not require patients to remain still, and is readily available in the department, the procedure will be performed while kids are waiting to get an X-ray, getting registered, or awaiting further treatment. On the data collection form, the investigators will document the patients' names, birthdates, medical record numbers so that their X-ray results can be compared to the ultrasound results for the purpose of the study. The information will be stored in a secure cabinet in a locked office. The investigators will also document which side is injured, where the patient feels pain and what the ankle looks like to help perform the ultrasound. The results of both the ultrasound and X-ray will be documented for each patient.
Interventions
- OTHER Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01341015
The ClinicalTrials.gov registry entry for NCT01341015 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound is the first listed.
NCT01341015 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01341015 about?
NCT01341015 is a clinical study titled "Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children". Objectives: A lot of children who injure their ankles come to the emergency department for an evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated wit...
What is the current status of trial NCT01341015?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2010-06. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01341015?
The interventions under investigation include: Ultrasound (OTHER).
Who is sponsoring clinical trial NCT01341015?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
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