Capillary Refill Time Measurement Utilizing Mobile Application in Children (CapApp)
May 17, 2024 updated by: University of Minnesota
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
193
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 17 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy children age 1 month to 17 years
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy and Precision of a Mobile Health Application (Cap App)
Time Frame: 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
|
Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
July 21, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 22, 2024
Last Update Submitted That Met QC Criteria
May 17, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- pending2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans on sharing results of the individual participant study data or aggregate study data with the participants.
The data will be kept blinded from the research team members at the time of collection and, thus, no information will be shared with the participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.