Trial Outcomes & Findings for Diagnostic Accuracy of Handheld vs Traditional Ultrasound (NCT NCT05196776)
NCT ID: NCT05196776
Last Updated: 2023-11-01
Results Overview
The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
1 day
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
Portable, Handheld Device
Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.
Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device.
|
Traditional, Cart-based Ultrasound
Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.
Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
COMPLETED
|
53
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Portable, Handheld Device
n=53 Participants
Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.
Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device.
|
Traditional, Cart-based Ultrasound
n=56 Participants
Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.
Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=53 Participants
|
57 years
n=56 Participants
|
59 years
n=109 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=53 Participants
|
34 Participants
n=56 Participants
|
61 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=53 Participants
|
22 Participants
n=56 Participants
|
48 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
53 Participants
n=53 Participants
|
56 Participants
n=56 Participants
|
109 Participants
n=109 Participants
|
PRIMARY outcome
Timeframe: 1 dayThe primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).
Outcome measures
| Measure |
Portable, Handheld Device
n=54 Participants
Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.
Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device.
|
Traditional, Cart-based Ultrasound
n=56 Participants
Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.
Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model.
|
|---|---|---|
|
Diagnostic Accuracy
|
53 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 1 dayUsing a Likert scale of 1-7 (1 = unable to assess image; 7 = highest quality), ultrasound fellowship-trained providers will assess the image quality of images obtained by each provide in the study.
Outcome measures
| Measure |
Portable, Handheld Device
n=53 Participants
Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.
Portable, handheld point-of-care ultrasound device: The patient will have an ultrasound performed using a handheld, portable device.
|
Traditional, Cart-based Ultrasound
n=56 Participants
Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.
Cart-based point-of-care ultrasound device: The patient will have an ultrasound performed using a traditional cart-based model.
|
|---|---|---|
|
Image Quality by Expert Review
|
4 score on a scale
Interval 1.0 to 7.0
|
5 score on a scale
Interval 1.0 to 7.0
|
Adverse Events
Portable, Handheld Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional, Cart-based Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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