Skip to main content
Clinical Trials/NCT03860311
NCT03860311
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country45 target enrollmentJuly 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Point-of-Care Bladder Ultrasound
Sponsor
University of Alabama at Birmingham
Enrollment
45
Locations
1
Primary Endpoint
Time to Successful Completion of Pelvic Ultrasound
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2019
End Date
May 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Ruffenach

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Age 8yr-18yrs
  • 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

Outcomes

Primary Outcomes

Time to Successful Completion of Pelvic Ultrasound

Time Frame: Baseline to 180 minutes

Time zero (order placed) to time completed (time pelvic ultrasound images are completed)

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials