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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Pelvic Pain
• Intervention / Treatment: Other: point-of-care ultrasound

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Hasbro Children's Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POCUS; Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.	Other: point-of-care ultrasound
No Intervention: Usual Care; Patients will be given consecutive IV fluid boluses until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Fill-To-Done (FTD) Time	Median time from enrollment to successful completion of TAPUS	on same day as study enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt	on same day as study enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Receiving IV Narcotics in the Emergency Department		day of enrollment
Total IV Fluids Given Prior to TAPUS		day of enrollment
TAPUS Result		day of enrollment
Disposition From ED		day of enrollment
Inter-rater Agreement	Agreement between the POCUS sonographer and the blinded reviewer	at close of study

Collaborators and Investigators

• Sponsor: Lifespan

Publications and helpful links

General Publications

• Dessie A, Steele D, Liu AR, Amanullah S, Constantine E. Point-of-Care Ultrasound Assessment of Bladder Fullness for Female Patients Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound in a Pediatric Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2018 Nov;72(5):571-580. doi: 10.1016/j.annemergmed.2018.04.010. Epub 2018 Jul 3.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): November 5, 2016
• Study Completion (Actual): November 5, 2016

Study Registration Dates

• First Submitted: September 24, 2016
• First Submitted That Met QC Criteria: October 2, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Pelvic Pain
• Other Study ID Numbers: 744799-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO