POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound

• Sponsor: Lifespan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02923245
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 14.2
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Pain; Pelvic Pain	Other: point-of-care ultrasound	N/A

Detailed Description

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:

1. Standard of care group - Patients will be given consecutive IV fluid boluses until sensation of maximum bladder fullness followed by transabdominal pelvic US performed by a radiologist or US technician.

2. Experimental group - Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS followed by transabdominal pelvic US performed by a radiologist or US technician.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Point-of-Care-Ultrasound Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound: A Randomized Controlled Trial
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Nov 5, 2016
• Actual Study Completion Date: Nov 5, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: POCUS 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.	Other: point-of-care ultrasound
No Intervention: Usual Care 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

Outcome Measures

Primary Outcome Measures

1. Median Fill-To-Done (FTD) Time [on same day as study enrollment]

   Median time from enrollment to successful completion of TAPUS

Secondary Outcome Measures

1. Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt [on same day as study enrollment]

Other Outcome Measures

1. Number of Participants Receiving IV Narcotics in the Emergency Department [day of enrollment]

2. Total IV Fluids Given Prior to TAPUS [day of enrollment]

3. TAPUS Result [day of enrollment]

4. Disposition From ED [day of enrollment]

5. Inter-rater Agreement [at close of study]

   Agreement between the POCUS sonographer and the blinded reviewer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers

Exclusion Criteria:

• History of genitourinary or pelvic anomalies (e.g. neurogenic bladder, urogenital malformation, ambiguous genitalia, Turner Syndrome, ureterocele, bladder diverticulum, imperforate hymen); history of pelvic surgery

• Critically ill patients who are unable to consent

• Sensation of maximal bladder fullness/need to void at time of start of the study

• Nonverbal patients or severe cognitive or language delay

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasbro Children's Hospital Emergency Department	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• Lifespan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Almaz Dessie, Fellow, Pediatric Emergency Medicine, Lifespan
• ClinicalTrials.gov Identifier: NCT02923245
• Other Study ID Numbers: 744799-9
• First Posted: Oct 4, 2016
• Last Update Posted: Mar 19, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pelvic Pain; Abdominal Pain

Study Results

Participant Flow

Arm/Group Title	Point-of-care Ultrasound (POCUS)	Usual Care (UC)
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	60	60
COMPLETED	58	59
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	POCUS	Usual Care	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	60	60	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.1 (2.43)	14.7 (2.34)	14.4 (2.39)
Sex: Female, Male (Count of Participants)
Female	60 100%	60 100%	120 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	31 51.7%	37 61.7%	68 56.7%
Non-Hispanic Black	5 8.3%	5 8.3%	10 8.3%
Hispanic	22 36.7%	14 23.3%	36 30%
Other	2 3.3%	4 6.7%	6 5%
Region of Enrollment (Count of Participants)
United States	60 100%	60 100%	120 100%
Body Mass Index (BMI) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	23.0 (4.81)	25.4 (6.57)	24.2 (5.86)
Time since last void (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	126.5	120.5	125
Time from TAPUS order by physician to study enrollment (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	32.0	34.5	32.5
Chief Complaint (Count of Participants)
Abdominal Pain	56 93.3%	50 83.3%	106 88.3%
Vomiting	3 5%	3 5%	6 5%
Dysuria/flank pain/hematuria	5 8.3%	5 8.3%	10 8.3%
Other	0 0%	3 5%	3 2.5%

Outcome Measures

1. Primary Outcome

Title	Median Fill-To-Done (FTD) Time
Description	Median time from enrollment to successful completion of TAPUS
Time Frame	on same day as study enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POCUS	Usual Care
Arm/Group Description	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	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.
Measure Participants	58	59
Median (Inter-Quartile Range) [minutes]	87.5	139

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	POCUS, Usual Care
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	49.7
	Confidence Interval	(2-Sided) 95%; 23.4 to 77.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	These confidence intervals correspond to the bootstrap analysis

2. Secondary Outcome

Title	Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt
Time Frame	on same day as study enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POCUS	Usual Care
Arm/Group Description	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	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.
Measure Participants	58	59
Count of Participants [Participants]	58 96.7%	50 83.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	POCUS, Usual Care
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Test of proportions
	Comments
Method of Estimation	Estimation Parameter	Difference in percentages
	Estimated Value	15.3
	Confidence Interval	(2-Sided) 95%; 5.3 to 25.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Other Pre-specified Outcome

Title	Number of Participants Receiving IV Narcotics in the Emergency Department
Time Frame	day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POCUS	Usual Care
Arm/Group Description	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	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.
Measure Participants	58	59
Count of Participants [Participants]	21 35%	26 43.3%

4. Other Pre-specified Outcome

Title	Total IV Fluids Given Prior to TAPUS
Time Frame	day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POCUS	Usual Care
Arm/Group Description	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	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.
Measure Participants	58	59
Mean (Standard Deviation) [ml/Kg]	19.4 (15.1)	22.9 (13.5)

5. Other Pre-specified Outcome

Title	TAPUS Result
Time Frame	day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POCUS	Usual Care
Arm/Group Description	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	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.
Measure Participants	58	59
Normal	46 76.7%	48 80%
Abnormal	12 20%	11 18.3%
Ovarian torsion	4 6.7%	2 3.3%
Simple ovarian cyst	1 1.7%	3 5%
Ruptured/hemorrhagic cyst	5 8.3%	5 8.3%
Other ovarian abnormality	2 3.3%	0 0%
Uterine anomaly	0 0%	1 1.7%
Pathologic free fluid	1 1.7%	2 3.3%
Hydrosalpinx	1 1.7%	0 0%

6. Other Pre-specified Outcome

Title	Disposition From ED
Time Frame	day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	POCUS	Usual Care
Arm/Group Description	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	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.
Measure Participants	58	59
Discharged home	43 71.7%	44 73.3%
Admit to ward	11 18.3%	11 18.3%
Admitted to operating room	5 8.3%	5 8.3%
Transferred	1 1.7%	0 0%

7. Other Pre-specified Outcome

Title	Inter-rater Agreement
Description	Agreement between the POCUS sonographer and the blinded reviewer
Time Frame	at close of study

Outcome Measure Data

Analysis Population Description

304 images were available for assessment of inter-rater reliability

Arm/Group Title	Bladder POCUS Images
Arm/Group Description	all saved POCUS images were de-identified and retrospectively reviewed by the study site's Director of Pediatric Emergency Ultrasound. The reviewer, blinded to the original assessment of the study sonographer, rated each image as small, medium, large, or unidentifiable.
Measure Participants	304
Number (95% Confidence Interval) [weighted kappa]	0.83

Adverse Events

Arm/Group Title	POCUS		Usual Care
Arm/Group Description	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		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.
All Cause Mortality
	POCUS		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Serious Adverse Events
	POCUS		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	POCUS		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.