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

The University of Alabama at Birmingham

Status: Completed

Conditions: Urethral Catheter; Point-of-Care Bladder Ultrasound

Treatments: Device: Bladder Ultrasound; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03860311

IRB-300002071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Bladder Ultrasound

Experimental group

Description:

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.

Treatment:

Device: Bladder Ultrasound

Standard of Care

Active Comparator group

Description:

Bladder (Urethral) Catheter group. The standard of care group will undergo placement of a urethral bladder catheter to allow retrograde filling of the bladder.

Treatment:

Other: Standard of Care