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| Name | Class |
|---|---|
| Wallace H. Coulter Foundation | OTHER |
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This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. We are not measuring the effect of the ultrasound examination on the subjects' outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Experimental ultrasound diagnosis agreement with final reference standard diagnosis | Agreement will be measured as simple agreement and with adjusted agreement (Cohen's kappa). Sensitivity and specificity will also be calculated by comparing the experimental ultrasound result with the final reference diagnosis. | Comparison of experimental ultrasound diagnosis with final reference diagnosis will occur at approximately 4 weeks (average) after date of experimental ultrasound exam, to allow clinical follow-up to occur. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of experimental ultrasound exam (seconds) | The duration of the experimental ultrasound exam in seconds will be digitally recorded at the time of its performance. We anticipate the ultrasound duration to be less than 600 seconds. | |
| Appendix visualized by experimental ultrasound (yes/no) |
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Inclusion Criteria:
Exclusion Criteria:
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Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis. The clinical diagnostic plan before subject enrollment must include abdominal ultrasound and/or abdominal CT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. |
| Experimental ultrasound image quality. | Visual analogue scale/Likert scale | 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |