- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129789
Volumetric Bladder Ultrasound Training for Pediatric Residents
March 27, 2018 updated by: Laura Watkins, Northwell Health
Volumetric Bladder Ultrasound Training for Pediatric Residents: Curriculum Implementation and Learning Trajectory
Monitoring fluid balance is crucial in the care of critically ill children.
There are several reasons urine output could be decreased.
For example, the bladder could be empty because the patient isn't making urine due to dehydration, or the bladder could be full but the patient unable to urinate due to obstruction of the bladder outlet.
It is prudent to distinguish this difference in the care of Pediatric Intensive Care Unit patients as the potential interventions vary and none is without potential drawbacks if used inappropriately.
At present, there is no standard way to determine whether an oliguric patient has a bladder that is under- or over-filled.
Bedside ultrasound is safe, non-invasive, painless, and relatively quick and can help assess bladder volume at the time of noted oliguria.
Several studies in pediatrics endorse the use of ultrasound to approximately measure urine volume.
Pediatric residents are frequently asked to manage patients' oliguria in the Pediatric Intensive Care Unit, however, they are not currently being trained how to use ultrasound to measure bladder volume.
The investigators hypothesize that following a structured learning plan, by the end of their one-month Pediatric Intensive Care Unit rotations, pediatric residents will be able to independently and accurately measure bladder volume by ultrasound.
Volumetric bladder ultrasound is an easily mastered bedside imaging technique.
Its implementation could positively affect care of the critically ill infant or child.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New Hyde Park, New York, United States, 11040
- Steven and Alexandra Cohen Childrens Medical Center of NY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- medical resident rotating through the Pediatric Intensive Care Unit
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
competency
Time Frame: 1 month
|
participant correctly performs and accurately interprets bladder volume measurements as outlined above three consecutive times
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-instruction questionnaire
Time Frame: 1 month
|
assess knowledge of basic ultrasound image acquisition and interpretation, confidence in ability to use volumetric bladder ultrasound, satisfaction with attainment of a new skill, and critical evaluation of the curriculum
|
1 month
|
|
skill retention
Time Frame: 3 months
|
test to determine if participants are able to correctly performs and accurately interprets bladder volume measurements 3 months after training
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 3, 2017
Primary Completion (ACTUAL)
November 12, 2017
Study Completion (ACTUAL)
November 12, 2017
Study Registration Dates
First Submitted
April 14, 2017
First Submitted That Met QC Criteria
April 22, 2017
First Posted (ACTUAL)
April 26, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2018
Last Update Submitted That Met QC Criteria
March 27, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 17-0032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ultrasound Training
-
Aalborg UniversityNordsimRecruitingUltrasound TrainingDenmark
-
Rigshospitalet, DenmarkCompletedUltrasound Training | Ultrasound Simulation | Ultrasound Assessment | Technology-enhanced Learning | Virtual Reality SimulationDenmark
-
Rigshospitalet, DenmarkCompletedSimulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills TransferDenmark
-
Tulane University Health Sciences CenterWithdrawnMedical Students,Lung Ultrasound,Simulation Training
-
Nanjing First Hospital, Nanjing Medical UniversityNot yet recruitingTraining | Ultrasound | Anesthesiology | Non-invasive | Residency | NeedleChina
-
University of AberdeenCompletedIn-plane Ultrasound Guided Needling TrainingUnited Kingdom
-
University of Turin, ItalyCompletedUltrasound | Medical Training | Medical Student | Simulation Based LearningItaly
-
University of New MexicoCompletedSimulator-based Training of Ultrasound-guided Regional AnesthesiaUnited States
-
Izmir University of EconomicsHealth Institutes of TurkeyActive, not recruitingChildren | Ultrasound | Pelvic Floor Muscle Training | Dysfunctional Voiding | DNSTurkey (Türkiye)
-
University of Wisconsin, MadisonCompletedHealthy | Exercise Training | Running | Elastography | Sport | Ultrasound ImagingUnited States
Clinical Trials on Volumetric Bladder Ultrasound Training
-
Washington University School of MedicineCompleted
-
Catholic University of the Sacred HeartCompletedUterine Cervical NeoplasmsItaly
-
Federal University of São PauloUnknown
-
Yale UniversityButterfly Network, IncCompletedVoiding Disorders | Voiding DysfunctionUnited States
-
Pamukkale UniversityRecruitingUrinary Bladder, OveractiveTurkey (Türkiye)
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Agri Ibrahim Cecen UniversityNot yet recruitingNURSING STUDENTS | NURSING EDUCATION | ESCAPE ROOM | BLADDER CATHETERIZATION
-
Saglik Bilimleri UniversitesiCompletedQuality of Life | Lower Urinary Tract Symptoms | Urinary IncontinenceTurkey
-
Hospital Italiano de Buenos AiresRecruitingOveractive Bladder SyndromeArgentina
-
Hospices Civils de LyonRecruitingCystic FibrosisFrance