POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound

Abdominal Pain Clinical Trial

Official title:

Point-of-Care-Ultrasound Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923245
• Other study ID #: 744799-9
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: November 5, 2016

Study information

• Verified date: March 2019
• Source: Lifespan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ultrasound (US) is the preferred imaging modality in the pediatric ED in the diagnostic evaluation of girls with suspected pelvic pathology. In the transabdominal approach, urine acts as a sonographic acoustic window to image the adnexa and uterus, but this requires a full bladder. Many high acuity pelvic pathologies presenting to the pediatric ED have significant morbidity and mortality associated with delays in diagnosis. Despite this, diagnostic pelvic US is often delayed by the need to fill the bladder, awaiting a patient's report of subjective sensation of bladder fullness. Images of the bladder using POCUS can be easily obtained at the bedside by emergency physicians, providing a quick assessment of the size and shape of the bladder that may be a more accurate, objective measure of bladder fullness. We aim to assess the utility of POCUS of the bladder compared to patient's sensation of bladder fullness in this clinical scenario.

This is a pragmatic, randomized controlled trial of a convenience sample of girls being treated in a pediatric ED who present with an indication for transabdominal pelvic US. Patients will be randomized to two groups:

1. Standard of care group - Patients will be given consecutive IV fluid boluses until sensation of maximum bladder fullness followed by transabdominal pelvic US performed by a radiologist or US technician.

2. Experimental group - Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS followed by transabdominal pelvic US performed by a radiologist or US technician.

Patients in both groups will be assessed at 30-minute intervals for sensation of bladder fullness on a 0-4 Likert Scale, total volume of IVF given per kilogram, and POCUS of the bladder. Overall time between initial ordering of transabdominal pelvic US (Time 0) to the time the patient went for successful US will be recorded and compared between the two groups. Success rate of first attempt at transabdominal pelvic US will also be recorded and compared between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 5, 2016
• Est. primary completion date: November 5, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Pelvic Pain

Intervention

Other:
• point-of-care ultrasound

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital Emergency Department	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Receiving IV Narcotics in the Emergency Department		day of enrollment
Other	Total IV Fluids Given Prior to TAPUS		day of enrollment
Other	TAPUS Result		day of enrollment
Other	Disposition From ED		day of enrollment
Other	Inter-rater Agreement	Agreement between the POCUS sonographer and the blinded reviewer	at close of study
Primary	Median Fill-To-Done (FTD) Time	Median time from enrollment to successful completion of TAPUS	on same day as study enrollment
Secondary	Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt		on same day as study enrollment