Ultrasound TrainingNCT03129789
Volumetric Bladder Ultrasound Training for Pediatric Residents
A study testing Volumetric Bladder Ultrasound Training in people with Ultrasound Training, run by Northwell Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Training
- What is being tested?
- Volumetric Bladder Ultrasound Training
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 12 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- medical resident rotating through the Pediatric Intensive Care Unit
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Steven and Alexandra Cohen Childrens Medical Center of NY
New Hyde Park, New York, 11040
About this study
Official title: 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.
- Conditions
- Ultrasound Training
- Being tested
- Volumetric Bladder Ultrasound Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Bladder Ultrasound TrainingOther
teaching residents to perform bladder volumetric ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
competency
participant correctly performs and accurately interprets bladder volume measurements as outlined above three consecutive times
Measured: 1 month
Secondary outcomes (2)
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
Measured: 1 month
skill retention
test to determine if participants are able to correctly performs and accurately interprets bladder volume measurements 3 months after training
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start3 Apr 2017
- Primary completion12 Nov 2017
- Study completion12 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound TrainingStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Watkins, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129789
- Sponsor's protocol ID
- 17-0032
- Status last verified
- Mar 2018
- First submitted
- 14 Apr 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Bladder Ultrasound Training for Pediatric Residents: Curriculum Implementation and Learning Trajectory
- ClinicalTrials.gov ID
- NCT03129789
- Acronym / sponsor ID
- 17-0032
- Conditions
- Ultrasound Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 12 Nov 2017 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- Single blind (participant)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- medical resident rotating through the Pediatric Intensive Care Unit
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric Bladder Ultrasound Trainingteaching residents to perform bladder volumetric ultrasound | Other | – |
Primary outcome
competency
Time frame: 1 month
participant correctly performs and accurately interprets bladder volume measurements as outlined above three consecutive times
2 secondary outcomes
post-instruction questionnaire
Time frame: 1 month
skill retention
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Bladder Ultrasound Training in people with Ultrasound Training, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
competency (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.