Trial Outcomes & Findings for POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound (NCT NCT02923245)
NCT ID: NCT02923245
Last Updated: 2019-03-19
Results Overview
Median time from enrollment to successful completion of TAPUS
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
on same day as study enrollment
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
ultrasound order was cancelled
|
2
|
1
|
Baseline Characteristics
POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound
Baseline characteristics by cohort
| Measure |
POCUS
n=60 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 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
|
Usual Care
n=60 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.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 2.43 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 2.34 • n=7 Participants
|
14.4 years
STANDARD_DEVIATION 2.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.0 kg/m2
STANDARD_DEVIATION 4.81 • n=5 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 6.57 • n=7 Participants
|
24.2 kg/m2
STANDARD_DEVIATION 5.86 • n=5 Participants
|
|
Time since last void
|
126.5 minutes
n=5 Participants
|
120.5 minutes
n=7 Participants
|
125 minutes
n=5 Participants
|
|
Time from TAPUS order by physician to study enrollment
|
32.0 minutes
n=5 Participants
|
34.5 minutes
n=7 Participants
|
32.5 minutes
n=5 Participants
|
|
Chief Complaint
Abdominal Pain
|
56 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Chief Complaint
Vomiting
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Chief Complaint
Dysuria/flank pain/hematuria
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Chief Complaint
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: on same day as study enrollmentMedian time from enrollment to successful completion of TAPUS
Outcome measures
| Measure |
POCUS
n=58 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 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
|
Usual Care
n=59 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.
|
|---|---|---|
|
Median Fill-To-Done (FTD) Time
|
87.5 minutes
Interval 67.0 to 126.0
|
139 minutes
Interval 92.0 to 193.0
|
SECONDARY outcome
Timeframe: on same day as study enrollmentOutcome measures
| Measure |
POCUS
n=58 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 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
|
Usual Care
n=59 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.
|
|---|---|---|
|
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt
|
58 Participants
|
50 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day of enrollmentOutcome measures
| Measure |
POCUS
n=58 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 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
|
Usual Care
n=59 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.
|
|---|---|---|
|
Number of Participants Receiving IV Narcotics in the Emergency Department
|
21 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day of enrollmentOutcome measures
| Measure |
POCUS
n=58 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 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
|
Usual Care
n=59 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.
|
|---|---|---|
|
Total IV Fluids Given Prior to TAPUS
|
19.4 ml/Kg
Standard Deviation 15.1
|
22.9 ml/Kg
Standard Deviation 13.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day of enrollmentOutcome measures
| Measure |
POCUS
n=58 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 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
|
Usual Care
n=59 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.
|
|---|---|---|
|
TAPUS Result
Normal
|
46 Participants
|
48 Participants
|
|
TAPUS Result
Abnormal
|
12 Participants
|
11 Participants
|
|
TAPUS Result
Ovarian torsion
|
4 Participants
|
2 Participants
|
|
TAPUS Result
Simple ovarian cyst
|
1 Participants
|
3 Participants
|
|
TAPUS Result
Ruptured/hemorrhagic cyst
|
5 Participants
|
5 Participants
|
|
TAPUS Result
Other ovarian abnormality
|
2 Participants
|
0 Participants
|
|
TAPUS Result
Uterine anomaly
|
0 Participants
|
1 Participants
|
|
TAPUS Result
Pathologic free fluid
|
1 Participants
|
2 Participants
|
|
TAPUS Result
Hydrosalpinx
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day of enrollmentOutcome measures
| Measure |
POCUS
n=58 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 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
|
Usual Care
n=59 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.
|
|---|---|---|
|
Disposition From ED
Discharged home
|
43 Participants
|
44 Participants
|
|
Disposition From ED
Admit to ward
|
11 Participants
|
11 Participants
|
|
Disposition From ED
Admitted to operating room
|
5 Participants
|
5 Participants
|
|
Disposition From ED
Transferred
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at close of studyPopulation: 304 images were available for assessment of inter-rater reliability
Agreement between the POCUS sonographer and the blinded reviewer
Outcome measures
| Measure |
POCUS
n=304 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 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
|
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.
|
|---|---|---|
|
Inter-rater Agreement
|
0.83 weighted kappa
Interval 0.79 to 0.87
|
—
|
Adverse Events
POCUS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place