Trial Outcomes & Findings for Hand-carried Ultrasound to Assess Hydronephrosis (NCT NCT03774719)
NCT ID: NCT03774719
Last Updated: 2024-07-24
Results Overview
The number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported
TERMINATED
NA
6 participants
Through study completion, up to an average of 1 day
2024-07-24
Participant Flow
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.
18 patients were screened, 6 met inclusion criteria, agreed to participate and were enrolled in the study.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hand-carried Ultrasound to Assess Hydronephrosis
Baseline characteristics by cohort
| Measure |
Hand-carried Ultrasound Arm
n=6 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
65.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to an average of 1 dayThe number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported
Outcome measures
| Measure |
Hand-carried Ultrasound Arm
n=6 Participants
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).
|
|---|---|
|
Number of Participants With Absence of Hydronephrosis
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to an average of 1 dayPopulation: Data regarding costs were not collected by research team at the time of the study.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to an average of 1 dayPopulation: Data regarding image quality was not collected by research team at the time of the study.
Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to an average of 1 dayPopulation: Data regarding technical difficulty of the study was not collected by the research team.
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.
Outcome measures
Outcome data not reported
Adverse Events
Hand-carried Ultrasound Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place