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

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ClinicalTrials.gov Identifier: NCT02923245
Recruitment Status : Completed
First Posted : October 4, 2016
Results First Posted : December 13, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Almaz Dessie, Lifespan

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : November 5, 2016
Actual Study Completion Date : November 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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



Primary Outcome Measures :
  1. Median Fill-To-Done (FTD) Time [ Time Frame: 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 [ Time Frame: on same day as study enrollment ]

Other Outcome Measures:
  1. Number of Participants Receiving IV Narcotics in the Emergency Department [ Time Frame: day of enrollment ]
  2. Total IV Fluids Given Prior to TAPUS [ Time Frame: day of enrollment ]
  3. TAPUS Result [ Time Frame: day of enrollment ]
  4. Disposition From ED [ Time Frame: day of enrollment ]
  5. Inter-rater Agreement [ Time Frame: at close of study ]
    Agreement between the POCUS sonographer and the blinded reviewer



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923245


Locations
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United States, Rhode Island
Hasbro Children's Hospital Emergency Department
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Lifespan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Almaz Dessie, Fellow, Pediatric Emergency Medicine, Lifespan
ClinicalTrials.gov Identifier: NCT02923245    
Other Study ID Numbers: 744799-9
First Posted: October 4, 2016    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pelvic Pain
Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive