Acute Kidney Injury, Hydronephrosis, Ultrasound
Conditions
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.
Interventions
DEVICEHand-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).
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Absence of Hydronephrosis | Through study completion, up to an average of 1 day | The number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direct Costs of Hand-carried Ultrasound | Through study completion, up to an average of 1 day | 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
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Image Quality | Through study completion, up to an average of 1 day | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
18 patients were screened, 6 met inclusion criteria, agreed to participate and were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Hand-carried Ultrasound Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 65.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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
Time frame: Through study completion, up to an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hand-carried Ultrasound Arm | Number of Participants With Absence of Hydronephrosis | 4 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.
Time frame: Through study completion, up to an average of 1 day
Population: Data regarding costs were not collected by research team at the time of the study.
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.
Time frame: Through study completion, up to an average of 1 day
Population: Data regarding technical difficulty of the study was not collected by the research team.
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.
Time frame: Through study completion, up to an average of 1 day
Population: Data regarding image quality was not collected by research team at the time of the study.