Hand-carried Ultrasound to Assess Hydronephrosis
Primary Purpose
Hydronephrosis, Ultrasound, Acute Kidney Injury
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand-carried ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Hydronephrosis
Eligibility Criteria
Inclusion Criteria:
- Age more than 18 years old
- Inpatient admission to Barnes Jewish Hospital (BJH)
- Patient has a diagnosis of Acute kidney injury (AKI) or Acute kidney Disease (AKD)
- Renal ultrasound ordered or performed within the past 4 hours
Exclusion Criteria:
- End-stage renal disease
- History of kidney transplant
- Stable chronic kidney disease
- Current diagnosis of renal cell carcinoma
- Pregnant women
- Morbid obesity (BMI >40)
- Rash or active skin lesions overlying the scanning area (left or right flank)
Sites / Locations
- Barnes Jewish Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hand-carried ultrasound arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Absence of hydronephrosis
None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03774719
First Posted
December 7, 2018
Last Updated
April 26, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03774719
Brief Title
Hand-carried Ultrasound to Assess Hydronephrosis
Official Title
Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Change in staffing, COVID, New US curriculum being developed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydronephrosis, Ultrasound, Acute Kidney Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hand-carried ultrasound arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hand-carried ultrasound
Other Intervention Name(s)
Point of care ultrasound, POCUS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Absence of hydronephrosis
Description
None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system)
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Direct costs of hand-carried ultrasound
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Ultrasound image quality
Description
Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist.
Time Frame
Through study completion, an average of 1 year
Title
Technical difficulty of the ultrasound study
Description
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.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age more than 18 years old
Inpatient admission to Barnes Jewish Hospital (BJH)
Patient has a diagnosis of Acute kidney injury (AKI) or Acute kidney Disease (AKD)
Renal ultrasound ordered or performed within the past 4 hours
Exclusion Criteria:
End-stage renal disease
History of kidney transplant
Stable chronic kidney disease
Current diagnosis of renal cell carcinoma
Pregnant women
Morbid obesity (BMI >40)
Rash or active skin lesions overlying the scanning area (left or right flank)
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hand-carried Ultrasound to Assess Hydronephrosis
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