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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03129789
Other study ID # 17-0032
Secondary ID
Status Completed
Phase N/A
First received April 14, 2017
Last updated March 27, 2018
Start date April 3, 2017
Est. completion date November 12, 2017

Study information

Verified date March 2018
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date November 12, 2017
Est. primary completion date November 12, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- medical resident rotating through the Pediatric Intensive Care Unit

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Volumetric Bladder Ultrasound Training
teaching residents to perform bladder volumetric ultrasound

Locations

Country Name City State
United States Steven and Alexandra Cohen Childrens Medical Center of NY New Hyde Park New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary competency participant correctly performs and accurately interprets bladder volume measurements as outlined above three consecutive times 1 month
Secondary post-instruction questionnaire 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
Secondary skill retention test to determine if participants are able to correctly performs and accurately interprets bladder volume measurements 3 months after training 3 months
See also
  Status Clinical Trial Phase
Completed NCT01895868 - Long-terms Effects of Simulation-based Ultrasound Training: A Randomized Trial N/A