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Hand-carried Ultrasound to Assess Hydronephrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774719
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fadi Tohme, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Hydronephrosis Ultrasound Acute Kidney Injury Device: Hand-carried ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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).
Other Names:
  • Point of care ultrasound
  • POCUS




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Fadi Tohme, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03774719    
Other Study ID Numbers: 1985080800
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Acute Kidney Injury
Hydronephrosis
Renal Insufficiency
Kidney Diseases
Urologic Diseases