Hand-carried Ultrasound to Assess Hydronephrosis

Acute Kidney Injury Clinical Trial

Official title:

Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03774719
• Other study ID #: 201903192-1985080800
• Status: Suspended
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 170
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hydronephrosis
• Ultrasound

Intervention

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).

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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, an average of 1 year
Other	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.	Through study completion, an average of 1 year
Primary	Absence of hydronephrosis	None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system)	Through study completion, an average of 1 year
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.	1 year