BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment

Not Applicable

Completed

• Conditions: Point-of-Care Bladder Ultrasound; Urethral Catheter
• Interventions: Device: Bladder Ultrasound; Other: Standard of Care

• Registration Number: NCT03860311
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

In this study patients presenting to the pediatric ER with abdominal or pelvic complaints will be randomized to urethral bladder catheter or bladder ultrasound to compare time to completion of successful pelvic ultrasound, as determined by full visualization of uterus and ovaries.

Detailed Description

In this study, we will enroll female pediatric emergency department (ED) patients presenting with a diagnosis of abdominal pain who may have a transabdominal pelvic ultrasound ordered by their treating physician (or nurse practitioner). In order to maximize the visualization of organs deep within the pelvis such as the ovaries and uterus, the patient's bladder must be full. The current practice at our institution, as well as numerous others, is to have a bladder catheter placed immediately when a transabdominal pelvic ultrasound is ordered, and then to fill the bladder in a retrograde manner in order to provide enhanced visualization of the pelvic structures. The process of inserting a bladder catheter into a pediatric patient is an invasive procedure which can be traumatic and painful to the patient. Additionally, if the patient's bladder is already full, this procedure may be unnecessary.

In this study, a point-of-care bladder ultrasound will be performed, upon enrollment of a patient by a study bedside sonographer (our pediatric emergency department nurse practitioners), to assess degree of bladder fullness. This measurement will then be repeated serially while the patient is receiving hydration and the ultrasound will be performed when the bladder is full. We hypothesize that this work flow will result in an equivalent time to transabdominal pelvic ultrasound completion and will reduce the number of potentially traumatic and painful, invasive urethral bladder catheterizations.

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Start: 2019-07-20
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Results First Submitted: 2021-12-20
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-28
• Last Update Submitted: 2022-05-28
• Results First Posted: 2022-06-01
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Age 8yr-18yrs
• Female
• Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
• No history of pelvic or bladder reconstructive surgery

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Exclusion Criteria

• Pregnancy (known)
• Critically ill patients
• Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
• Chronic renal disease
• Patients presenting outside the defined treatment windows

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder Ultrasound	Bladder Ultrasound	The bladder ultrasound group will undergo point-of-care ultrasound upon enrollment, and bladder ultrasound will be repeated every 30 minutes, unless the patient's bladder is full at time of initial scan.
Standard of Care	Standard of Care	Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.

Primary Outcome Measures

Name	Time	Method
Time to Successful Completion of Pelvic Ultrasound	Baseline to 180 minutes	Time zero (order placed) to time completed (time pelvic ultrasound images are completed)

Secondary Outcome Measures

Name	Time	Method
Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)	When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes	All participating patients, in either arm, will be given a single-question on pain related to their receipt of bladder ultrasound(s) or bladder catheter. The VNRS uses a 0-10 scale accompanied by faces that pictorially represent the level of pain, 0 being no pain, and 10 being the worst pain. Measurements will start at time when bladder ultrasound(s) are performed OR time when bladder catheter is inserted) to time of completion (time pelvic ultrasound is completed).

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States