NCT03129789

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

April 14, 2017

Last Update Submit

March 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • competency

    participant correctly performs and accurately interprets bladder volume measurements as outlined above three consecutive times

    1 month

Secondary Outcomes (2)

  • post-instruction questionnaire

    1 month

  • skill retention

    3 months

Interventions

teaching residents to perform bladder volumetric ultrasound

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • medical resident rotating through the Pediatric Intensive Care Unit

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steven and Alexandra Cohen Childrens Medical Center of NY

New Hyde Park, New York, 11040, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants perform ultrasound and the principle investigator is unaware of the identity of the participant
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 26, 2017

Study Start

April 3, 2017

Primary Completion

November 12, 2017

Study Completion

November 12, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations