N/A
N=120
POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound
Abdominal Pain · Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02923245 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Median Fill-To-Done (FTD) Time — 87.5; 139 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- point-of-care ultrasound (Other)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- Female
- Sponsor
- Lifespan
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Fill-To-Done (FTD) Time |
87.5; 139 | — |
| SECONDARY Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt |
58; 50 | 0.006 sig |
Summary
The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more quickly determine adequate bladder fullness to successfully perform transabdominal pelvic ultrasound than patient's perception of bladder fullness.
Eligibility Criteria
Inclusion Criteria
- Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers
Exclusion Criteria
- History of genitourinary or pelvic anomalies (e.g. neurogenic bladder, urogenital malformation, ambiguous genitalia, Turner Syndrome, ureterocele, bladder diverticulum, imperforate hymen); history of pelvic surgery
- Critically ill patients who are unable to consent
- Sensation of maximal bladder fullness/need to void at time of start of the study
- Nonverbal patients or severe cognitive or language delay
Data sourced from ClinicalTrials.gov (NCT02923245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.