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Change in staffing, COVID, New US curriculum being developed
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This study evaluates if trainees can accurately rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will undergo a short ultrasound training program. Patients will be adults that are hospitalized and have acute or subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive and negative predictive value of HCU compared to radiology performed ultrasound, and calculate potential cost savings to the patient and to the healthcare system.
Hand-carried ultrasound is an increasingly popular imaging modality and is widely used by emergency physicians, intensivists, trauma doctors and cardiologists. Renal ultrasonography is commonly ordered for patients with acute kidney injury, with a main focus on identifying obstruction of the collecting system, a rare but potentially reversible cause of acute kidney injury.
This study's aim is to evaluate if nephrology and internal medicine trainees can accurately rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will undergo a short, uniform and well described ultrasound training program. Patients will be adults that are hospitalized and have acute or subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive and negative predictive value of HCU compared to radiology performed ultrasound, and calculate potential cost savings to the patient and to the healthcare system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-carried ultrasound arm | Experimental | This is the only arm of the study. It will be comprised of 154 inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-carried ultrasound | Device | Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Absence of Hydronephrosis | The number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported | Through study completion, up to an average of 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Direct Costs of Hand-carried Ultrasound | Direct costs in $ of hand-carried ultrasound will be calculated and compared to the costs of radiology performed ultrasound. For hand-carried ultrasound, this will include costs of purchasing the device, training costs, yearly depreciation of the hand-carried ultrasound device. For radiology performed ultrasound, this will include the sonographer's fee, radiologist fee for interpretation of the result, transportation fee by hospital transport and depreciation of the ultrasound machine. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound Image Quality | Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist. | Through study completion, up to an average of 1 day |
| Technical Difficulty of the Ultrasound Study |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
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18 patients were screened, 6 met inclusion criteria, agreed to participate and were enrolled in the study.
Participants were recruited after presenting to the hospital between May 2019 and April 2023. First participant was enrolled May 6, 2019 and last participant enrolled May 24, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hand-carried Ultrasound Arm | This is the only arm of the study. It will include inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis. Hand-carried ultrasound: Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hand-carried Ultrasound Arm | This is the only arm of the study. It will include inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis. Hand-carried ultrasound: Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Absence of Hydronephrosis | The number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported | Posted | Count of Participants | Participants | Through study completion, up to an average of 1 day |
|
Time from start of ultrasound evaluation to end of ultrasound evaluation, up to 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hand-carried Ultrasound Arm | This is the only arm of the study. It will be comprised of 154 inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis. Hand-carried ultrasound: Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA). |
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Single center, study terminated did not reach enrollment target due to change in PI and COVID pandemic. No statistical analysis was performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gonzalo Matzumura | Washington University in Saint Louis | 3143627211 | g.matzumuraumemoto@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2019 | May 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2022 | Jul 1, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006869 | Hydronephrosis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Through study completion, up to an average of 1 day |
How technically difficult was it for the trainees to obtain the images (patient intubated, obesity etc.) as graded by the trainees who performed the ultrasound scans themselves. Trainees will grade difficulty using the following measurement scale (1) Technically easy: trainee able to get clear images of both kidneys within a timeframe of 10 minutes (2) Technically challenging: Trainee able to get clear images of kidneys but requiring more than 10 minutes of scanning time (3) Technically difficult: trainee unable to get clear images of both kidneys independent of time spent scanning. |
| Through study completion, up to an average of 1 day |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Direct Costs of Hand-carried Ultrasound | Direct costs in $ of hand-carried ultrasound will be calculated and compared to the costs of radiology performed ultrasound. For hand-carried ultrasound, this will include costs of purchasing the device, training costs, yearly depreciation of the hand-carried ultrasound device. For radiology performed ultrasound, this will include the sonographer's fee, radiologist fee for interpretation of the result, transportation fee by hospital transport and depreciation of the ultrasound machine. | Data regarding costs were not collected by research team at the time of the study. | Posted | Through study completion, up to an average of 1 day |
|
|
| Other Pre-specified | Ultrasound Image Quality | Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist. | Data regarding image quality was not collected by research team at the time of the study. | Posted | Through study completion, up to an average of 1 day |
|
|
| Other Pre-specified | Technical Difficulty of the Ultrasound Study | How technically difficult was it for the trainees to obtain the images (patient intubated, obesity etc.) as graded by the trainees who performed the ultrasound scans themselves. Trainees will grade difficulty using the following measurement scale (1) Technically easy: trainee able to get clear images of both kidneys within a timeframe of 10 minutes (2) Technically challenging: Trainee able to get clear images of kidneys but requiring more than 10 minutes of scanning time (3) Technically difficult: trainee unable to get clear images of both kidneys independent of time spent scanning. | Data regarding technical difficulty of the study was not collected by the research team. | Posted | Through study completion, up to an average of 1 day |
|
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |