Point-of-Care Bladder Ultrasound, Urethral Catheter
Conditions
Keywords
Ovarian Torsion, Point-of-Care, Pelvic pain, Bedside Ultrasound
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.
Interventions
DEVICEBladder Ultrasound
Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.
OTHERStandard of Care
Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Bladder Ultrasound: Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound. | 22 |
| 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.
Standard of Care: Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures. | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Bladder Ultrasound | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 15.33 years STANDARD_DEVIATION 1.98 | 15.00 years STANDARD_DEVIATION 2.091 | 14.7 years STANDARD_DEVIATION 2.183 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 31 Participants | 17 Participants |
| Region of Enrollment United States | 22 participants | 45 participants | 23 participants |
| Sex: Female, Male Female | 22 Participants | 45 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
Time to Successful Completion of Pelvic Ultrasound
Time zero (order placed) to time completed (time pelvic ultrasound images are completed)
Time frame: Baseline to 180 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bladder Ultrasound | Time to Successful Completion of Pelvic Ultrasound | 103.95 minutes |
| Standard of Care | Time to Successful Completion of Pelvic Ultrasound | 92.82 minutes |
Secondary
Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)
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).
Time frame: When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bladder Ultrasound | Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS) | 3.60 units on a scale |
| Standard of Care | Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS) | 6.23 units on a scale |