Trial Outcomes & Findings for Capillary Refill Time Measurement Utilizing Mobile Application in Children (NCT NCT05472116)
NCT ID: NCT05472116
Last Updated: 2024-05-22
Results Overview
Capillary refill time (CRT) of Cap App compared to two manual methods
Recruitment status
COMPLETED
Target enrollment
193 participants
Primary outcome timeframe
Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
Mobile Health Application
Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App).
|
|---|---|
|
Overall Study
STARTED
|
193
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capillary Refill Time Measurement Utilizing Mobile Application in Children
Baseline characteristics by cohort
| Measure |
Mobile Health Application
n=152 Participants
Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App).
|
|---|---|
|
Age, Categorical
<=18 years
|
152 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
82 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
69 Participants
n=5 Participants
|
|
Sex/Gender, Customized
unreported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time it takes for blood to return to issue on the fingertip after pressure application for 5 secondsCapillary refill time (CRT) of Cap App compared to two manual methods
Outcome measures
| Measure |
Mobile Health Application
n=152 Participants
Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App).
|
|---|---|
|
Accuracy and Precision of a Mobile Health Application (Cap App)
|
0.01 seconds
Standard Deviation 1.31
|
Adverse Events
Mobile Health Application
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