Abdominal PainNCT02923245
POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound
A study testing point-of-care ultrasound in people with Abdominal Pain and Pelvic Pain, run by Lifespan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 18 years, women only
- Conditions the study is for
- Abdominal Pain, Pelvic Pain
- What is being tested?
- point-of-care ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 5 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital Emergency Department
Providence, Rhode Island, 02903
About this study
Official title: Point-of-Care-Ultrasound Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound: A Randomized Controlled Trial
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.
Read the detailed description
Ultrasound (US) is the preferred imaging modality in the pediatric ED in the diagnostic evaluation of girls with suspected pelvic pathology. In the transabdominal approach, urine acts as a sonographic acoustic window to image the adnexa and uterus, but this requires a full bladder. Many high acuity pelvic pathologies presenting to the pediatric ED have significant morbidity and mortality associated with delays in diagnosis. Despite this, diagnostic pelvic US is often delayed by the need to fill the bladder, awaiting a patient's report of subjective sensation of bladder fullness. Images of the bladder using POCUS can be easily obtained at the bedside by emergency physicians, providing a quick assessment of the size and shape of the bladder that may be a more accurate, objective measure of bladder fullness. We aim to assess the utility of POCUS of the bladder compared to patient's sensation of bladder fullness in this clinical scenario.
This is a pragmatic, randomized controlled trial of a convenience sample of girls being treated in a pediatric ED who present with an indication for transabdominal pelvic US. Patients will be randomized to two groups:
- Standard of care group - Patients will be given consecutive IV fluid boluses until sensation of maximum bladder fullness followed by transabdominal pelvic US performed by a radiologist or US technician.
- Experimental group - Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS followed by transabdominal pelvic US performed by a radiologist or US technician.
Patients in both groups will be assessed at 30-minute intervals for sensation of bladder fullness on a 0-4 Likert Scale, total volume of IVF given per kilogram, and POCUS of the bladder. Overall time between initial ordering of transabdominal pelvic US (Time 0) to the time the patient went for successful US will be recorded and compared between the two groups. Success rate of first attempt at transabdominal pelvic US will also be recorded and compared between the two groups.
- Conditions
- Abdominal Pain, Pelvic Pain
- Being tested
- point-of-care ultrasound
- Medical subject headings
- Abdominal Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point-of-care ultrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Fill-To-Done (FTD) Time
Median time from enrollment to successful completion of TAPUS
Measured: on same day as study enrollment
Secondary outcomes (1)
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt
Measured: on same day as study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2015
- Primary completion5 Nov 2016
- Study completion5 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almaz Dessie, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923245
- Sponsor's protocol ID
- 744799-9
- Status last verified
- Mar 2019
- First submitted
- 24 Sep 2016
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29980460
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care-Ultrasound Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02923245
- Acronym / sponsor ID
- 744799-9
- Conditions
- Abdominal Pain, Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 5 Nov 2016 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ultrasound (US) is the preferred imaging modality in the pediatric ED in the diagnostic evaluation of girls with suspected pelvic pathology. In the transabdominal approach, urine acts as a sonographic acoustic window to image the adnexa and uterus, but this requires a full bladder. Many high acuity pelvic pathologies presenting to the pediatric ED have significant morbidity and mortality associated with delays in diagnosis. Despite this, diagnostic pelvic US is often delayed by the need to fill the bladder, awaiting a patient's report of subjective sensation of bladder fullness. Images of the bladder using POCUS can be easily obtained at the bedside by emergency physicians, providing a quick assessment of the size and shape of the bladder that may be a more accurate, objective measure of bladder fullness. We aim to assess the utility of POCUS of the bladder compared to patient's sensation of bladder fullness in this clinical scenario.
This is a pragmatic, randomized controlled trial of a convenience sample of girls being treated in a pediatric ED who present with an indication for transabdominal pelvic US. Patients will be randomized to two groups:
- Standard of care group - Patients will be given consecutive IV fluid boluses until sensation of maximum bladder fullness followed by transabdominal pelvic US performed by a radiologist or US technician.
- Experimental group - Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS followed by transabdominal pelvic US performed by a radiologist or US technician.
Patients in both groups will be assessed at 30-minute intervals for sensation of bladder fullness on a 0-4 Likert Scale, total volume of IVF given per kilogram, and POCUS of the bladder. Overall time between initial ordering of transabdominal pelvic US (Time 0) to the time the patient went for successful US will be recorded and compared between the two groups. Success rate of first attempt at transabdominal pelvic US will also be recorded and compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS | Experimental | Other: point-of-care ultrasoundPatients 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. |
| 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| point-of-care ultrasound | Other | POCUS |
Primary outcome
Median Fill-To-Done (FTD) Time
Time frame: on same day as study enrollment
Median time from enrollment to successful completion of TAPUS
1 secondary outcome
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt
Time frame: on same day as study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29980460Dessie 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.
- 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 point-of-care ultrasound in people with Abdominal Pain and Pelvic Pain, run by Lifespan 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 4 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 19 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Fill-To-Done (FTD) Time (time frame: on same day as study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923245, which also lists 1 linked publication.
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 19 Mar 2019.