Hand-carried Ultrasound to Assess Hydronephrosis
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|ClinicalTrials.gov Identifier: NCT03774719|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hydronephrosis Ultrasound Acute Kidney Injury||Device: Hand-carried ultrasound||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: 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.
Device: 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).
- Absence of hydronephrosis [ Time Frame: Through study completion, an average of 1 year ]None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system)
- Direct costs of hand-carried ultrasound [ Time Frame: 1 year ]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.
- Ultrasound image quality [ Time Frame: Through study completion, an average of 1 year ]Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist.
- Technical difficulty of the ultrasound study [ Time Frame: Through study completion, an average of 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774719
|United States, Missouri|
|Barnes Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|