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

NCT02923245 | Completed Results

• 1 other identifier: 744799-9
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Median Fill-To-Done (FTD) Time

  Median time from enrollment to successful completion of TAPUS

  on same day as study enrollment

Secondary Outcomes (1)

• Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt

  on same day as study enrollment

Other Outcomes (5)

• 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

  day of enrollment

Study Arms (2)

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.

Other: point-of-care ultrasound

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

Interventions

point-of-care ultrasound OTHER

POCUS

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Hasbro Children's Hospital Emergency Department

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 29980460 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Results Point of Contact

• Title: Almaz Dessie, MD
• Organization: Brown University

almaz@brown.edu

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Pediatric Emergency Medicine

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2015
• Primary Completion: November 5, 2016
• Study Completion: November 5, 2016
• Last Updated: March 19, 2019
• Results First Posted: December 13, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)