Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POCUS | Experimental | 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. |
|
| Usual Care | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| point-of-care ultrasound | Other |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt | on same day as study enrollment |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasbro Children's Hospital Emergency Department | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29980460 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Point-of-care Ultrasound (POCUS) | Patients will be given consecutive intravenous (IV) fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues until a full bladder is visualized by the emergency department (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. point-of-care ultrasound |
| FG001 | Usual Care (UC) | Patients will be given consecutive intravenous (IV) fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | POCUS | Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues 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. point-of-care ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Fill-To-Done (FTD) Time | Median time from enrollment to successful completion of TAPUS | Posted | Median | Inter-Quartile Range | minutes | on same day as study enrollment |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POCUS | Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues 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. point-of-care ultrasound |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Almaz Dessie, MD | Brown University | almaz@brown.edu |
Not provided
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| BG001 | Usual Care | Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Time since last void | Median | Inter-Quartile Range | minutes |
|
| Time from TAPUS order by physician to study enrollment | Median | Inter-Quartile Range | minutes |
|
| Chief Complaint | Count of Participants | Participants |
|
Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues 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.
|
|
|
| Secondary | Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt | Posted | Count of Participants | Participants | on same day as study enrollment |
|
|
|
|
| Other Pre-specified | Number of Participants Receiving IV Narcotics in the Emergency Department | Posted | Count of Participants | Participants | day of enrollment |
|
|
|
| Other Pre-specified | Total IV Fluids Given Prior to TAPUS | Posted | Mean | Standard Deviation | ml/Kg | day of enrollment |
|
|
|
| Other Pre-specified | TAPUS Result | Posted | Count of Participants | Participants | day of enrollment |
|
|
|
| Other Pre-specified | Disposition From ED | Posted | Count of Participants | Participants | day of enrollment |
|
|
|
| Other Pre-specified | Inter-rater Agreement | Agreement between the POCUS sonographer and the blinded reviewer | 304 images were available for assessment of inter-rater reliability | Posted | Number | 95% Confidence Interval | weighted kappa | at close of study |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Usual Care | Patients will be given consecutive IV fluid boluses and assessed at 30 minute intervals for sensation of bladder fullness on a 0-4 Likert scale and POCUS assessments of the bladder. Protocol continues 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. | 0 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided
Not provided
| D012817 | Signs and Symptoms, Digestive |
| Ovarian torsion |
|
| Simple ovarian cyst |
|
| Ruptured/hemorrhagic cyst |
|
| Other ovarian abnormality |
|
| Uterine anomaly |
|
| Pathologic free fluid |
|
| Hydrosalpinx |
|
| Admitted to operating room |
|
| Transferred |
|