Healthy Children (1 Month to 17 Years Old)
Conditions
Keywords
Capillary Refill, Mobile Health Application, Pediatrics
Brief summary
To determine the accuracy and precision of capillary refill time measurement using a mobile health application (Cap App) in a healthy pediatric population. This will be a cross-sectional study measuring the capillary refill time in a healthy pediatric population using both the Cap App and two additional manual methods which will serve as the comparison.
Interventions
DEVICEMobile Health application (CapApp)
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).
Sponsors
University of Minnesota
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy children aged 1 month to 17 years
Exclusion criteria
* Fever or hypothermia * Chronic illness including cardiovascular or renal disease * Severe injury or blood loss * Dehydration * Raynaud's phenomenon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy and Precision of a Mobile Health Application (Cap App) | Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds | Capillary refill time (CRT) of Cap App compared to two manual methods |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 152 |
| Total | 152 |
Baseline characteristics
| Characteristic | Mobile Health Application |
|---|---|
| Age, Categorical <=18 years | 152 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 114 Participants |
| Sex/Gender, Customized Female | 82 Participants |
| Sex/Gender, Customized Male | 69 Participants |
| Sex/Gender, Customized unreported | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Accuracy and Precision of a Mobile Health Application (Cap App)
Capillary refill time (CRT) of Cap App compared to two manual methods
Time frame: Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Application | Accuracy and Precision of a Mobile Health Application (Cap App) | 0.01 seconds | Standard Deviation 1.31 |