Capillary Refill Time Measurement Utilizing Mobile Application in Children
Conditions: Healthy Children (1 Month to 17 Years Old)
Sponsor: University of Minnesota

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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Template Revised On: 03/31/2022 
 
ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
☒ No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
☐ Yes 
☒ No 
 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☒ Yes 
☐ No 
 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
 
See: 
https://policy.umn.edu/research/indide  
☐ Yes 
☒ No 
 
Require Scientific Review? Not 
sure?  See guidance in the 
Investigator Manual (HRP-
103). 
 
Documentation of scientific merit must 
be provided.   
Contact: hrpp@umn.edu  
☐ Yes 
☒ No 
 
Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
Complete the CPRC application process.  
Contact: ccprc@umn.edu  
☐ Yes 
☒ No 
 
Include the use of radiation? 
(x-ray imaging, 
radiopharmaceuticals, external 
beam or brachytherapy) 
Complete the AURPC Human Use 
Application and follow instructions on 
the form for submission to the AURPC 
committee. 
Contact: barmstro@umn.edu  
Approval 
from these 
committees 
must be 
received 
prior to IRB 
approval;  
 
These 
groups 
☐ Yes 
☒ No 
 
Use the Center for Magnetic 
Resonance Research (CMRR) 
or MR from Masonic Institute 
for the Developing Brain 
(MIDB) as a study location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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☐ Yes 
☒ No 
 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
Complete the IBC application via 
eprotocol.umn.edu 
 
each have 
their own 
application 
process.  
☐ Yes 
☒ No 
Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
Contact OBAO for submission 
instructions and guidance 
☒ Yes 
☐ No 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of 
this protocol. 
Contact: privacy@umn.edu  
☐ Yes 
☒ No 
 
Use data from CTSI Best 
Practices Integrated 
Informatics Core? 
 
Formerly the AHC Information 
Exchange (IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: bpic@umn.edu  
Approval 
must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
may be 
required. 
 
☐ Yes 
☒ No 
 
Use the Biorepository and 
Laboratory Services to collect 
tissue for research? 
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: Jenny Pham 
Pham0435@umn.edu 
☐ Yes 
☒ No 
 
Have a PI or study team 
member with a conflict of 
interest? 
The CoI ancillary review will be 
assigned to your study by IRB staff 
Contact: becca002@umn.edu  
☒ Yes 
☐ No 
 
Need to be registered on 
clinicaltrials.gov? 
If you select “No” in ETHOS, the 
clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
Contact: fencl003@umn.edu   
☒ Yes 
☐ No 
 
Require registration in 
OnCore? 
If you select “No” or “I Don’t Know” in 
ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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PROTOCOL COVER PAGE 
 
Protocol Title 
Capillary Refill Time Measurement Utilizing Mobile Application 
(Cap App) in Children 
Principal 
Investigator/Faculty 
Advisor 
Name: Jonathan R. Strutt, MD 
Department: Pediatrics 
Telephone Number: (314) 578-8045 
Email Address: strutt@umn.edu 
Student 
Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
I believe Scientific Assessment is not required. 
IND/IDE # (if 
applicable) 
IDE-NSR 
IND/IDE Holder 
N/A. 
Investigational Drug 
Services # (if 
applicable) 
N/A. 
Version 
Number/Date: 
Version 3, October 27, 2022 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1  
8/16/2022 
data point collected for CapApp 
measurement & added research to 
the approved recruitment sign 
language 
no 
2 
10/27/2022 
Add CTSI monitoring 
no 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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Table of Contents 
 
1.0 
Objectives .......................................................................................................................... 6 
2.0 
Background ........................................................................................................................ 7 
3.0 
Study Endpoints/Events/Outcomes .................................................................................. 9 
4.0 
Study Intervention(s)/Investigational Agent(s) ................................................................. 9 
5.0 
Procedures Involved ........................................................................................................ 11 
6.0 
Data and Specimen Banking ............................................................................................ 12 
7.0 
Sharing of Results with Participants ................................................................................ 13 
8.0 
Study Population ............................................................................................................. 13 
9.0 
Vulnerable Populations ................................................................................................... 14 
10.0 
Local Number of Participants .......................................................................................... 17 
11.0 
Local Recruitment Methods ............................................................................................ 17 
12.0 
Withdrawal of Participants .............................................................................................. 18 
13.0 
Risks to Participants ........................................................................................................ 19 
14.0 
Potential Benefits to Participants .................................................................................... 19 
15.0 
Statistical Considerations ................................................................................................ 19 
16.0 
Health Information and Privacy Compliance .................................................................. 19 
17.0 
Confidentiality ................................................................................................................. 24 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................. 25 
19.0 
Provisions to Protect the Privacy Interests of Participants ............................................. 25 
20.0 
Compensation for Research-Related Injury .................................................................... 26 
21.0 
Consent Process .............................................................................................................. 26 
22.0 
Setting .............................................................................................................................. 28 
23.0 
Multi-Site Research ......................................................................................................... 28 
24.0 
Coordinating Center Research ........................................................................................ 28 
25.0 
Resources Available ......................................................................................................... 28 
26.0 
References ....................................................................................................................... 29 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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ABBREVIATIONS/DEFINITIONS 
• 
Cap App – Capillary Refill Time Mobile Application 
• 
CRT – Capillary Refill Time 
• 
ED – Emergency Department 
• 
IV – Intravenous  
• 
PPG - Photoplethysmography 
• 
PI - Principal Investigator 
• 
IND/IDE - Investigational New Drug/Investigational Device Exemption 
• 
OIT - Office of Information Technology 
• 
FDA - Food and Drug Administration 
• 
IRB - Institutional Review Board 
• 
AE - Adverse Event 
• 
LAR - Legal Adult Representative 
• 
DUA - Data Use Agreement 
• 
NSR - Non Significant Risk  
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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1.0 
Objectives 
1.1 Purpose: 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. 
2.0 
Background 
1.1 Significance of Research Question/Purpose: A prolonged CRT is used to determine 
inadequate skin perfusion (1).  It is a subjective physical exam finding which can 
be used to aid in the diagnosis of shock from any cause, such as hypovolemic 
(dehydration), septic, or hemorrhagic.  This quick test which can be performed in 
any medical setting is vital to the assessment of circulation in children as 
recommended by the Pediatric Advanced Life Support course (2).  Despite its 
clinical importance, there is low interobserver agreement among providers 
performing this routine clinical test (3).  Additionally, Capillary refill time (CRT) is 
the time it takes for blood to return to tissue (on the fingertip, for instance) 
blanched by pressure. there is significant age and sex variation of normal CRT 
amongst otherwise healthy patients (1).  The subjective nature of the CRT also 
limits the utility and improved clinical detail that might be obtained by 
quantifying the CRT more precisely.  As currently employed, the clinician 
identifies the CRT as either normal or prolonged.  This binary classification of CRT 
may be limiting its clinical usefulness.  For instance, improved access to precise 
measurement of CRT may help improve the accuracy of the level of dehydration 
(mild/moderate/severe) and, thereby, reduce unnecessary emergency 
department (ED) visits and/or intravenous (IV) treatments.  In addition, CRT has 
been utilized to assess, diagnose, or monitor many medical conditions in the 
pediatric population, such as hypovolemic, hemorrhagic, and septic shock. 
The Cap App is a mobile smartphone application that we developed to measure 
CRT.  It utilizes photoplethysmography (PPG) to calculate CRT.  Previous research 
has shown that PPG — a technique that optically measures the blood volume 
changes in the microvascular bed of tissue via light absorption — can be achieved 
using the combination of a smartphone’s flash and camera.  To use such systems, 
a patient simply covers the flash and camera simultaneously using their 
finger.  The amount of light that is reflected to the camera depends on the 
presence of two components: tissue, which remains constant over time; and 
blood, which varies over time. Therefore, the camera records and subsequently 
analyzes relative color changes to reproduce the PPG waveform, irrespective of a 
person’s skin tone.  This technique has been used to estimate heart rate (7), 
pulse-transit time (8), and even hemoglobin (9), and we have applied this 
approach in Cap App to measure capillary refill time.  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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Beyond making the capillary refill time assessment more precise, Cap App also 
makes the procedure more repeatable by ensuring that sufficient blanching has 
been achieved by using a combination of the PPG waveform and motion sensing. 
As the patient presses their finger against the camera, the phone vibrates, and its 
motion sensor measures how much the phone vibrates; harder pressure dampens 
the phone’s vibration and causes a weaker signal (10).  As blood leaves the 
fingertip, the amplitude of the PPG signal diminishes and eventually stabilizes to a 
brighter color due to blanching. 
Improved access to precise measurement of capillary refill time will help expand 
the capabilities of experienced providers who are treating patients remotely 
through telehealth or less experienced providers treating patients in remote 
locations.  This is especially important in low-resource settings or regions remote 
from specialty centers where providers may not be as experienced in the care of 
children. Triaging care for conditions such as pediatric dehydration is challenging 
due to lack of resources, especially in developing countries. However, even in 
well-developed nations, access to specialized care for pediatric patients is still 
lacking.  Pediatric specialized care in the United States is largely regionalized.  
Most seriously ill children present first to community hospitals where resources 
and expertise to treat these children may be limited.  In fact, more than 90 
percent of emergency department visits for children in the United States are to 
non-specialty facilities (11).  Admission rates for large specialty pediatric hospitals 
are 2-4 times larger than general emergency departments suggesting that the 
majority of providers caring for children have limited experience in treating 
higher acuity pediatric conditions (12).  Additionally, in the setting of rising health 
care costs, many parents and other non-professional caregivers are increasingly 
seeking health information from non-traditional sources such as mobile 
smartphones. 
2.1 Preliminary Data: A pilot study is ongoing on healthy adult volunteers.  This study 
is not yet published in a peer-reviewed journal.  The study’s main objective is to 
compare CRT measured from Cap App versus manual visual assessment under 
differing temperature controls.  The study has enrolled 19 participants, age 20-34; 
9 female, 10 male.  There is some variance in skin tone.  We controlled for 5 
temperature conditions (30°C, 27.5°C, 25°C, 22.5°C, 20°C) utilizing an ice bath to 
determine variance of CRT measurement under progressively colder 
temperatures.  The results show that Cap App measures a longer CRT with greater 
variance in relation to the colder temperatures.  It tends to overestimate CRT for 
darker skin tones.  Overall, CRT is longer for Cap App than for a correlated, 
manual CRT measurement. 
2.2 Existing Literature: Capillary refill has been utilized to assess, diagnose, or monitor 
many medical conditions in the pediatric population, such as hypovolemic and 
septic shock.  Dehydration is one example of hypovolemic shock.  The diagnosis of 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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pediatric dehydration is largely based on clinical findings.  There have been 
multiple clinical dehydration scoring systems developed to assess for dehydration 
in pediatric patients, but none are particularly accurate at differentiating levels of 
severity (4).  Capillary refill has been shown to be the best individual clinical 
predictor of acute dehydration in children (5).  Previous research has shown that 
video recording of capillary refill time is a promising tool to diagnose dehydration 
in children.  Video computation of capillary refill time has been shown to be more 
accurate at diagnosing significant dehydration in children than overall clinical 
assessment by trained pediatric specialists (6). Improved access to precise 
measurement of capillary refill time may help improve the accuracy of the level of 
dehydration (mild/moderate/severe) and, thereby, reduce unnecessary ED visits 
and IV treatments.  Our aim with this study is to establish normative values of 
capillary refill as measured by the Cap App so that we may utilize its accuracy to 
improve the detection of peripheral perfusion abnormalities in conditions such as 
dehydration.   
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: Determining the accuracy and precision of a 
mobile health application (Cap App) to measure CRT in an otherwise healthy 
pediatric patient population. 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): To establish normal values of CRT 
via Cap App for healthy children of varying age ranges, determine if subject 
characteristics such as skin tone, skin temperature, sex, or age affect the CRT 
measured via the Cap App, and determine if the CRT measured via the Cap App 
correlates to the manual measurement of CRT in healthy children at varying age 
ranges. 
4.0 
Study Intervention(s)/Investigational Agent(s) 
1.2 
Description: Cap App – mobile smartphone application used to measure CRT.  
The CapApp is a smartphone mobile application created through a partnership with the 
University of Washington, The University of Toronto, and The University of Minnesota.  
Management of the application will primarily be the responsibility of The University of 
Washington Ubiquitous Computing Lab led by Shwetak Patel, PhD and PhD candidate, 
Chunjong Park. Oversight of the project will be from The University of Toronto 
Assistant Professor of Computer Science, Alex Mariakakis, PhD. A standard Android 
smartphone running a custom smartphone application will be used for collecting 
fingertip videos, motion data, demographics (e.g., age, sex, temperature), and skin 
tone using the Fitzpatrick skin color scale. The app will start up and allow the user to 
enter a study ID and age, sex, race, skin tone, skin temperature, room temperature, 
core temperature, weight, vital signs (heart rate, blood pressure) and any underlying 
diagnosis. No other identifying information will be stored, including date of birth, 
name, audio, or fingerprint.  The user is asked to place their right index finger on the 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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front camera. Once the app confirms that the finger is correctly placed, it asks the user 
to apply pressure against the phone. When the app detects whether the user is 
applying enough pressure for the specified time, it asks the user to relax the pressure. 
A function to notate any required assistance for the child in pressing on the 
smartphone to measure the capillary refill will also be noted. This will be needed 
especially for younger children and infants as it may cause a difference in how to 
interpret the results of the measurement. The app collects accelerometer/gyroscope 
data and video recording of the fingertip. The fingertip recording will not collect 
fingerprint identification information.  The collected data will be uploaded to the cloud 
server on a secure data storage platform, Box. 
 
The device, as used in this study protocol, does not meet the criteria of a serious risk 
device under 21 CRF 812.3(m) and therefore is a non-significant risk (NSR) device.  The 
device meets the criteria of a NSR-IDE for the following reasons: 
▪ 
This device is not intended as an implant and does not present a potential for 
serious risk to health, safety, or welfare of a subject. 
▪ 
Is not purported or represented to be for a use in supporting or sustaining 
human life and presents a potential for serious risk to the health, safety or 
welfare of a subject. 
▪ 
Is not for a use of substantial importance in diagnosing, curing, mitigating, or 
treating disease, or otherwise preventing impairment of human health and does 
not present a potential for serious risk to the health, safety or welfare of a 
subject. 
▪ 
Does not otherwise present a potential for serious risk to the health, safety or 
welfare of a subject.  
▪ 
We will comply with the abbreviated requirements in 21 CFR 812.2(b). 
 
1.3 Drug/Device Handling: The Cap App mobile software will be uploaded onto two 
smartphone devices. The smartphones will be locked with a passcode and only 
study team members will have access to that passcode. 
Those devices will be stored in the Pediatric Emergency Department where only 
study personnel will have access to them for purposes of enrolling participants 
and collecting the study data.  
As this device will be used at The Driven to Discover Research Facility at the 
Minnesota State Fair (2022), the device will be transferred and remain in 
possession of a study team meeting at all times.  
4.1 Biosafety: NA  
4.2 
Stem Cells: NA 
4.3 
Fetal Tissue: NA 

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PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
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5.0 
Procedures Involved 
5.1 Study Design: The study design will be a cross-sectional study.  The observation 
will be to collect the CRT from a population of healthy pediatric participants.  
Participants who meet the inclusion criteria will have their CRT measured using 
both the manual measurement (to include both human and computer 
annotation) and mobile health application (Cap App). 
Study Procedures: Cap App CRT measurement: Children will be placed in a seated 
position, and their hand resting on a table top in a resting position. The research 
assistant will use a smartphone with the mobile health application (Cap App) to 
measure the CRT.  The phone will be placed on a tabletop with the front facing camera 
face up.  The subject’s index fingertip will be placed onto the camera of the 
smartphone with minimal pressure.  The finger will then be pressed firmly against the 
camera for a total of 5 seconds and then released from firm pressure while still 
contacting the camera with instructions from the Cap App.  The research assistant then 
presses “stop” on the Cap App device.  The Cap App will then measure the amount of 
time it takes for blood to refill the capillary bed as evidenced by the signal return to 
normal of light shining on the capillary bed.  This measurement will be kept blinded to 
the researcher and be uploaded to a secure web-based cloud server, Box, for analysis.  
To establish the reproducibility of the index test (or the ability of the test to be 
accurately replicated), the CRT will be repeated at least twice on the index fingertip 
with at least 15 seconds between tests, and twice on the index finger of the opposite 
hand, all within 30 to 60 seconds of each other.  
 
Manual CRT measurement: Children will be placed in a seated position with their hand 
raised slightly above the level of the heart on a table. A tripod will be set up for the 
smartphone to video record the capillary refill test by facing the table from the top.  
The recording will begin, and audio will not be recorded.  The research assistant will 
compress the index finger of the participant for 5 seconds with transparent plastic and 
then release the pressure, after which the plastic will be removed from the field of 
view of the camera.  The camera recording will then be stopped once the research 
assistant has determined the color has returned to its original color.  To establish the 
reproducibility of the index test (or the ability of the test to be accurately replicated), 
the CRT will be repeated at least twice on 1 fingertip with at least 15 seconds between 
tests, and twice on the index finger of the opposite hand, all within 30 to 60 seconds of 
each other.  The video, without audio, will be stored in the University of Minnesota’s 
secure online storage platform, Box. For analysis the research study team will complete 
the following: 
- 
Human annotation from manual CRT measurement: The video will be 
annotated blindly by a separate research team member than the one who 
performs the CRT manual measurement.  The CRT will be measured as the 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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amount of time required for the index finger color to return to its pre-
compressed color.  The measurement will be annotated by a trained human 
from the video recording by measuring the CRT with a stopwatch, as is the 
current standard.   
 
- 
Computer annotation from manual CRT measurement: The same video from 
the manual CRT measurement will be used for the computer annotation.  A 
research team member will manually select a section of the finger for use in the 
analysis and then a computer will analyze the color using signal processing.  This 
annotation will serve as the gold standard of what is possible for human visual 
CRT measurement. 
 
Individually Identifiable Health Information: Electronic data collection forms will be 
used to collect all relevant variables to help interpret CRT measurements in the context 
of the healthy patient populations.  In brief, the following is the information that will be 
collected: 
1)  For healthy participants:   
a. Demographics (race/ethnicity, gender, age).  
b. Temperature (environment, core, skin at finger).  
c. Clinical (weight, blood pressure, heart rate, oxygen saturation, skin 
tone) 
d. CRT measurement (manual video, Cap App)  
e. Any underlying diagnosis (medical history 
5.2 Study Duration:  
● Total study length: 15 months including 3 months for protocol 
development and IRB approval, 6 months for data collection, and 6 
months for data analysis.  
● Individual participant: time expected to complete the study is 30 
minutes; 20 minutes for enrollment screening and consent and 10 
minutes for the CRT measurements 
5.3 Use of radiation: NA  
5.4 Use of Center for Magnetic Resonance Research: NA 
6.0 
Data and Specimen Banking 
6.1 Storage and Access: The individual participant study data will be collected in the 
smartphone application during the research encounter, under an assigned ID#.  
Once the data has been collected and uploaded to a secure web-based data 
storage site (Box) the individual devices will be cleared of any individual 
participant data. 

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App) in Children 
 
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1.4 Data: Study data will be uploaded from the smartphone application to a secure 
web-based platform (Box) for access by study team members only.  The data (de-
identified) will be shared with the University of Washington under a Data Use 
Agreement (DUA).  The DUA is in process with SPA. De-identified data will be 
stored in Box for future use by other researchers.  Data will be available 
immediately following study completion with no end date. Researchers, including 
those outside the study, whose proposed use of the data has been approved by 
the PI will have access to the data to achieve aims in the approved proposal.  
AHC-IE will not be used.   
For publishing of data derived from the study: Publishing of these data may be 
required. Federal funders, granting agencies, and journal publishers increasingly 
require datasets be made publicly available-often immediately upon associated 
article publication.  If this is the case, all data published will be fully de-identified. 
6.2 Release/Sharing: Should the investigators pursue data sharing, future studies 
seeking to compile data acquired from this protocol will obtain IRB approval 
before doing so.  In the event that this occurs, only investigators or study 
personnel listed in an IRB-approved protocol pertaining to the data compilation 
will have access to this data.  The requested data will be released to the 
researchers in a de-identified manner. Any scientist who is willing to partner with 
a study investigator may submit a manuscript proposal or an ancillary study 
proposal.  Once the PI approves the proposal, the investigator and the data 
coordinating center enter into a Data Use Agreement (DUA).  After the signing of 
the agreement, this institution and coordinating team will distribute the 
requested data to the investigator.  A nominal fee is charged for preparing the 
datasets. 
7.0 
Sharing of Results with Participants 
7.1 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. 
7.2 Sharing of genetic testing: NA 
8.0 
Study Population 
8.1 Inclusion Criteria: Healthy children aged 1 month – 17 years.   
8.2 Exclusion Criteria:  
● Fever or hypothermia 
● Chronic illness including cardiovascular or renal disease 
● Severe injury or blood loss 

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PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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● Dehydration (including vomiting and/or diarrhea) 
● Raynaud’s phenomenon 
● Children who do not have a parent or legal guardian present to obtain 
consent 
8.3 Screening: Convenience sample of participants presenting at the D2D: The Driven 
to Discover Research Facility at the Minnesota State Fair August 25 - September 
5, 2022 will be screened for inclusion and exclusion criteria.  All those who are 
eligible will have the opportunity to enroll.  We will utilize a script to assist in the 
screening process to ensure that all information is presented accurately and 
uniformly to all potential participants. 
9.0 
Vulnerable Populations 
9.1 Vulnerable Populations:  
 
Population / Group 
Identify whether any of the 
following populations will be focus 
of the research (targeted), 
included, but not necessarily the 
focus or excluded from 
participation in the study. 
Children 
Primary focus of the research 
Pregnant women/fetuses/neonates 
Excluded 
Prisoners 
Excluded 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Excluded 
Non-English speakers 
Excluded 
Those unable to read (illiterate) 
included but not the focus 
Employees of the researcher 
Excluded 

MEDICAL PROTOCOL (HRP-590) 
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Students of the researcher 
Excluded 
Undervalued or disenfranchised 
social group 
included but not the focus 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Excluded 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
included but not the focus 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
included but not the focus 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
included but not the focus 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
included but not the focus 
 
9.2 Additional Safeguards, if any, to ensure inclusion is appropriate:  
Children: This research is designed specifically to assess the effectiveness of a 
mobile health application to measure CRT in children; therefore, children must be 
included in the study to answer the research question. Children are the targeted 
population for this study because the study aims could not be assessed without 
children. Study procedures have been minimized to exclude all unnecessary 

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procedures that would not contribute to the scientific objective. All participants 
will be provided assurance of confidentiality, the freedom to decline to participate 
and the right to withdraw at any time without penalty. Consent process for 
children is described in section 21.5 
 
Individual or group that is approached for participation in research during a 
stressful situation such as emergency room setting, childbirth (labor), etc.: All 
efforts will be made to consent the patient or LAR during a non-stressful time. 
Extra caution will be taken as to not coerce the potential participant. They will be 
encouraged to ask questions of the research team or and discuss with their 
support if needed. Individuals who are noticeably nervous or stressed at that time 
will not be consented. 
 
Those unable to read (Illiterate): Patients and/or their LAR who are illiterate may 
not be known, research staff will not be asking a direct question about literacy to 
potential participants. However, if it is made known to us that the patient or their 
LAR is illiterate, we will take extra care to go through the consent form and read it 
to the potential participant. An unbiased witness (non- study team member) will 
be present to attest that the consent form was described accurately. This witness 
will also sign the consent form. 
 
Individual or group that is disadvantaged in the distribution of social goods and 
services such as income, housing, or healthcare: Undervalued or disadvantaged 
people may not be known, research staff will not be asking a direct question about 
socioeconomic status to potential participants. The voluntary nature of study 
participation will be emphasized along with appropriate consent obtained as 
required per this protocol. Participation of not will not affect any relationship with 
this research team, the University of Minnesota or M Health. 
 
Individual or group with a fear of negative consequences for not participating in 
the research (e.g. institutionalization, deportation, disclosure of stigmatizing 
behavior). Research staff will not be asking a direct questions of potential 
participants that could reveal such information. The voluntary nature of study 
participation will be emphasized along with appropriate consent obtained as 
required per this protocol. Participation of not will not affect any relationship with 
this research team, the University of Minnesota or M Health.  
 

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Any other circumstance/dynamic that could increase vulnerability to coercion or 
exploitation that might influence consent to research or decision to continue in 
research. Research staff will not be asking a direct questions of potential 
participants that could reveal such information. The voluntary nature of study 
participation will be emphasized along with appropriate consent obtained as 
required per this protocol. Participation of not will not affect any relationship with 
this research team, the University of Minnesota or M Health. 
 
Individual or group with a serious health condition for which there are no 
satisfactory standard treatments may be included unless exclusionary (see section 
8.2). The study is non-interventional and will not impact care or treatment of the 
child, therefore felt that can be included in study enrollment. If there are 
questions, the research team will defer to the investigator for inclusion. 
9.3 If research includes potential for direct benefit to participants, provide rationale 
for any exclusions indicated in the table above: NA/no direct benefit to 
participation 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented: A minimum of 240 participants are 
needed for data analysis and we anticipate needing to consent 300+ participants 
to meet that goal to account for errors in data collection, data upload, and/or 
participant withdrawal.  We will attempt to match participants by age group and 
skin tone to control for expected variance of CRT measurement. 
11.0 Local Recruitment Methods 
11.1 Recruitment Process: Convenience sample of participants presenting at D2D: The 
Driven to Discover Research Facility at the Minnesota State Fair, August 25 - 
September 5, 2022. 
11.2 Identification of Potential Participants: All participants interested in enrolling in 
our study presenting at the D2D: The Driven to Discover Research Facility at the 
Minnesota State Fair will be screened using the inclusion/exclusion criteria.  We 
will then approach the parent/guardian for consent of children meeting the 
inclusion criteria. 
11.3 Recruitment Materials: A conspicuous study sign will be made. The sign will have 
the following verbiage: “Cap App: a mobile health smartphone application to 
measure finger blood flow in children. You may be asked to participate in an 
optional research study to learn more about the utility of a new smartphone 
application that could one day improve the diagnosis of several medical 
conditions in children, including dehydration. ”  This sign will be in the clearly 
visible in the D2D Research Facility at the Minnesota State Fair 

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11.4 Payment: No payment will be provided but all participants will receive a 
complimentary University of Minnesota Backpack provided through D2D.      
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances:  
Participants are free to withdraw from participation in the study at any time upon 
request. An investigator may discontinue or withdraw a participant from the 
study for the following reasons: 
● If any clinical adverse event (AE), or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of 
the participant. This may include if there are any signs of discomfort (i.e. crying, 
tantrums, fits, screaming).  
● If the participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation 
12.2 Withdrawal Procedures: If a participant/parent/guardian wishes to withdraw or 
we determine that the participant should withdraw, we will terminate data 
collection and discuss with the participant the reasons for withdrawal. All data 
collected up to that point will be used in analysis. This will be made known in the 
consent form. 
12.3 Termination Procedures:  
This study may be temporarily suspended or prematurely terminated if there is 
sufficient reasonable cause. Written notification, documenting the reason for study 
suspension or termination, will be provided by the suspending or terminating party to 
the funding agency. If the study is prematurely terminated or suspended, the PI will 
promptly inform the IRB and will provide the reason(s) for the termination or 
suspension. The study team will notify the participants of the study termination.  
Circumstances that may warrant termination or suspension include, but are not 
limited to: 
● Determination of unexpected, significant, or unacceptable risk to 
participants 
● Demonstration of efficacy that would warrant stopping 
● Insufficient compliance to protocol requirements 
● Data that are not sufficiently complete and/or evaluable 
● Determination that the primary endpoint has been met 
● Determination of futility 
The study may resume once concerns about safety, protocol compliance, and/or data 
quality procedures are addressed and satisfy the sponsor, IRB and/or FDA. 

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Data collected for the study prior to the study termination will be handled in the 
following manner: 
● If the study is terminated due to safety reasons, the data related to AEs will be 
evaluated.  
If the study is terminated for any other reason, the regulatory and/or institutional 
document/data retention policies will apply. 
13.0 Risks to Participants 
13.1 Foreseeable Risks:  
Although we cannot eliminate the loss of confidentiality or privacy, this study 
does involve the collection of private health information.  All personal 
information will be assigned a random study identification number and stored on 
a secure database.  The personal information of the participants will not be 
recorded in the study database.  
The smartphone camera will only record participants’ hand/fingertip so no 
sensitive information should be recorded by the smartphone camera. The 
smartphone has ability for video only so that audio is not applicable.  
Nevertheless, participants will be made aware of the nature of the video 
recordings ahead of time and will have the option of having video recordings re-
done or deleted.  
We will provide a brief explanation of the procedure to the participants old 
enough to understand (age >3 years) so that they can know what to expect with 
finger compression.  The explanation will include language similar to: “Your 
fingertip will be squished tightly for 5 seconds, but then it will stop.  You’ll have 
this done four times on both your right and left finger, but we may ask you to 
have it happen again.” 
13.2 Reproduction Risks: NA 
13.3 Risks to Others: NA 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: There are no direct benefits for participation in this study.  This 
information will be used to help determine effectiveness of a mobile health 
application at measuring CRT in children. 
15.0 Statistical Considerations 
15.1 
Data Analysis Plan: We plan to utilize a Biostatistical Design and Analysis Center 
biostatistician from the Clinical and Translational Science Institute in the statistical 
analysis of our data.  We will compare the manual method of CRT (human annotation 
with a stopwatch and computer analysis) and Cap App measurement of CRT amongst 
each individual subject.  We will then create a normal range of Cap App CRT based on 

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age of the subject in one of five categories (1-3 months, 3-12 months, 1-5 years, 5-12 
years, and 12-17 years), sex (male or female), and race (skin tone).  We will include a 
description of the primary diagnosis, vital signs (heart rate, blood pressure, oxygen 
saturation), temperature (room, patient core, and skin), and second, third, and fourth 
measurements of CRT (used for intra-rater reliability).  Missing data will be 
documented as noted and the record will be excluded from analysis as applicable.  
Minimal missing data is expected, so missing data will not be imputed. 
 
15.2 
Power Analysis: The goal of this study is to determine the precision of the 
capillary refill time measured via the smartphone application, so no formal power 
calculation was performed.  
 
15.3 
Statistical Analysis: We will recruit pediatrics patients aged 1 month to 17 years 
who are presenting to the D2D: The Driven to Discover Research Facility at the 
Minnesota State Fair.  Descriptive statistics will be used to summarize the data 
collected.  For the primary outcome, we will calculate mean CRT along with 95% 
confidence intervals, both overall and by age group, sex, and skin tone.  We will 
attempt to enroll a minimum of 48 patients per age group for a total of 240 
patients.  Initial results showed an average standard deviation of 0.663 seconds across 
all patients at normal hand temperature.  When the sample size is 48, a two-sided 95% 
confidence interval for a mean will extend ± 0.188 seconds.  For a total sample size of 
240, a two-sided 95% confidence interval for a mean will extend ± 0.084 seconds.  
Human annotation of a video recording using a stopwatch will be used to measure the 
manual CRT measurement and we will perform computer annotation of the video 
recording as a gold standard.  For human and computer annotations we will calculate 
inter-rater reliability by repeating annotations with a different observer on 10% of a 
random group of CRT measurements.  Inter-rater reliability will be evaluated using 
intraclass correlation coefficients (ICCs) and Bland–Altman plots. 
15.4 
Data Integrity: The research assistant will obtain study eConsent and fill the 
data collection forms which will be embedded into the Cap App and will be password 
protected.  The data forms, video recordings for human and computer annotation, and 
Cap App CRT measurement will then be uploaded to a secure web-based data storage 
platform, Box. The research assistant will erase the data on the smartphones every 
shift and will store them in the in a secure location at all times.  The consent forms, 
assent forms, and case report forms will be electronic (UMN REDCap eConsent).  No 
paper copies will be utilized. 
16.0 Health Information and Privacy Compliance 
16.1 
Select which of the following is applicable to your research: 

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☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
 
X I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research:  
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
 
16.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
X I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe: Describe in detail the source of the information. 
 
16.3 
Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
Only participants who voluntarily approach our study team members with 
interest in participating in our study will be screened.  
16.4 
Approximate number of records required for review: 

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We anticipate screening approximately 300 children for enrollment with a total 
enrollment goal of at least 240 participants, with aim for 48 in each of five age 
categories (1-3 months, 3–12 months, 1 - 5 years, 5-12 years, and 12-17). No 
access to the child’s medical record will be required as enrolled during the D2D 
State Fair location.  
16.5 
Please describe how you will communicate with research participants during 
the course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication 
with research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
X Communication with research participants will take place outside of 
treatment settings. If this box is selected, please describe the type of 
communication and how it will be received by participants. Participants will 
express interest in person by presenting to the D2D: The Driven to Discover 
Research Facility at the Minnesota State Fair.  
 
16.6 
Explain how the research team has legitimate access to patients/potential 
participants: The research team will be permitted to access sources of private 
information because all participants will be required to sign a HIPAA waiver at the time 
of informed consent. 
16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 

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X In the University’s Box Secure Storage (box.umn.edu) 
 X  Store 
 
X Analyze 
X Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices:  
 
 
☐ Store 
☐ Analyze 
☐ Share 
X Other: see mobile device below 
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet 
computer such as an iPad or a smartform (iPhone or Android devices) that you 
have not already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
X I will use a mobile device such as a smartphone not previously listed: The 
demographics, vital signs, underlying diagnosis, and CRT data (including video for 
the manual CRT measurement) will be collected from a smartphone which is 
running the Cap App mobile phone application. The data collected will be de-
identified and uploaded to a secure Box platform hosted by UMN.   
16.8 Consultants. Vendors. Third Parties. : A DUA will be signed to share de-identified 
research data with The University of Washington and The University of Toronto, 
who are collaborators on the CapApp.  
16.9 Links to identifiable data: 
All data will be de-identified. Study staff will assign an identification code for each 
participant to identify each individual record but it will not be used to link back to 
each individual participant. That same identification code will be transferred into 
the Box database. Any internal data reports will use only these codes and will not 
use any identifiable information. Any external data reports, abstracts, 
publications, presentations, etc. will present de-identified, grouped, and/or 
aggregate data. Any reports to the University of Minnesota IRB (such as Adverse 
Event reporting and annual renewal reports) will be kept confidential; they will 
not include participant- identifiable information; only the participant’s 
identification code will be used 

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16.10 Sharing of Data with Research Team Members Only IRB-approved members of 
the study team will have access to the data through the methods already 
indicated in this section.  
16.11 Storage of Documents: Electronic documents will be stored in a secure database 
only accessible to research staff. We will maintain the de-identified patient 
characteristic data, de-identified video, and Cap App data for future use by 
other researchers (in UMN Box). 
16.12 Disposal of Documents: We will erase individual data forms from electronic 
smartphones upon transfer to Box file.    
17.0 Confidentiality 
17.1 Data Security: 
Computers used will be University owned and meet University compliance 
requirements and pertinent external regulations. All computers are password 
protected and meet a basic level of security to protect the integrity of the data 
and network. These precautions also procure a high level of security to protect 
the integrity of the data and network as well as comply with OIT and data storage 
requirements within Fairview and the University of MN. Data will be stored on a 
password protected computer behind a firewall protected user drive.   
Training: All study staff will be appropriately trained to this protocol and its 
requirements, including maintenance of participant confidentiality. 
Authorization of access: Only designated IRB-approved staff will have access to 
the data. The data collected will not be reported to any medical provide nor 
provided to the patient or adult/legal guardian.  The CRT measurements collected 
will be kept blinded to the participants and to the research staff and will not be 
interpreted or cause any change to the treatment or care of the child. 
Password protection/encryption/physical controls: All data will be stored in the 
UMN Box system which is secured and HIPAA compliant. Consents will be 
retained in the HIPAA compliant REDCap platform that will only be accessed by 
the study team.   
Confidentiality:  
Individual participant information obtained because of this study is considered 
confidential. Information will be accessible to authorized parties or personnel 
only.  All records will be identified in a manner designed to maintain participant 
confidentiality.  
No paper records will be kept. 
Separation of Identifiers and data:  

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Participants will be assigned a unique identifier. Any participant records or 
datasets will contain the identifier only; participant names and associated unique 
identifier will be kept on a separate log (Box). The capillary refill measurements 
will be kept blinded to the research team member and no action will be taken on 
aberrant measurements. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data Integrity Monitoring.  
Data collection is the responsibility of the study staff under the supervision of the 
principal investigator. The investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. This includes 
ensuring that the study activities are occurring as per protocol. 
The study team will also utilize the University of Minnesota CTSI monitoring 
services for external monitoring. The monitors are trained in GCP and federal 
regulatory requirements through the University of Minnesota Clinical and 
Translational Science Institute (CTSI), and is supported by the NIH Clinical and 
Translational Science Award at the University of Minnesota: UL1TR000114. 
Monitoring will provide review of the study protocol and participant enrollment 
and data collection. This use is in order to ensure that the study team is 
conducting the study according to protocol, SOPS and federal and GCP regulatory 
requirements. 
Monitoring will be conducted at minimum on a 6 month basis with request by the 
investigator or monitor to increase monitoring if there are concerns. They will be 
provided access to all study files, regulatory and participant, and conduct their 
visits in-person or remotely based with the study team available for questions and 
instructions. The PI will communicate with the monitors to discuss any findings. 
The monitors will allow a process of addressing any findings at the time of the 
visit and then provide a final follow-up report to the study team. The study team 
will address prior to the next visit. This report will be provided to the University of 
Minnesota HRPP quality assurance program as per institutional requirements. 
18.2 Data Safety Monitoring.  
Based on the minimal risk nature of this study, data safety monitoring will be 
under the supervision of the principal investigator. The investigator will review 
data with the study team and if any noted adverse events do occur, the study 
may be suspended and/or terminated (section 12.3) with appropriate reporting 
to the IRB and any study participants. 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy: Confidentiality of the research participants will be maintained. 
All data will be stored electronically on a secure data storage platform and will 

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not be released without consent of participants. Data to be used in scientific 
presentations or publications will not contain participant identifiers. All material 
will be used exclusively for research. Data obtained will be stored in a confidential 
database without direct identifiers. The principal investigator and designated 
study staff will have access to the linkages, which will be stored in a separate, 
secured location. Hard copies of data will not be kept. Any study files that will be 
shared with the University of Minnesota will remove patient identifying 
information. 
19.2 Access to Participants: All research staff listed on this application are trained in 
research ethics and are eligible to conduct human subject research. Participants 
will be fully informed of the ways in which their data will/may be used during the 
informed consent process.  The research team has been trained in conducting 
these conversations and the participants are also assessed for their 
understanding of consent prior to initiating any study procedures. 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: If research-related activities result in 
an injury, treatment will be provided to the participant (e.g., first aid, emergency 
treatment, and follow-up care as needed). Care for such injuries will be billed in 
the ordinary manner to the participant or the participant’s insurance company. 
20.2 Contract Language: NA. 
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained):  
Participants will self-report with interest at the D2D: The Driven to Discover 
Research Facility at the Minnesota State Fair.      
● The consent will take place in the research space provided at the D2D: 
The Driven to Discover Research Facility. 
● There is no built-in waiting period available between informing the 
prospective participants and obtaining the consent.  If the subject 
requests a waiting period to help make an informed decision, a 
reasonable time will be allotted to accommodate that request as 
deemed appropriate by the treating provider. 
● We will provide a copy of the current ICF to the participant, in advance if 
possible. 
● ICF will be read to the participant after which questions will be invited 
and responded to. 
● The participant will be given time to discuss consent with others, 
including taking ICF home to consider. 
● The researcher will determine if the potential participant understands 
the information presented through the consent process and 

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comprehends study details. It is under the discretion of the researcher, 
and per D2D requirements, that if there is suspect of alcohol 
intoxication, consent will not proceed at that time.  
● We will obtain consent from one parent/legally authorized 
representative and assent from the participant if old enough. 
● This will be obtained by electronically in-person utilizing the D2D 
provided devices (i.e. iPads) with electronic signature capture.  
● An electronic copy of the signed ICF/HIPAA forms will be emailed to the 
participant. 
● We will ensure ongoing consent though voluntary participation in the 
study including performing the procedure.  We will ensure voluntary 
participation at each stage of the study through verbal confirmation. 
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained): NA 
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained): A script will be used to screen potential 
participants for enrollment, prior to obtaining consent.  This script will ensure 
that all information is presented accurately and uniformly to all potential 
participants. No PHI or study procedures will occur until formal consent process is 
conducted and signed consent/assent is provided.  
21.4 Non-English Speaking Participants: Non-English Speaking will be excluded at the 
time of D2D State Fair based on inability to ensure appropriate interpreter 
services for consent and participation. When services or location allows for the 
potential enrollment of non-English speakers, the study team will complete a 
modification for enrollment. 
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age): 
Infant to 7 years old 
Parent(s) interested in hearing more about the study will be informed in detail of 
the purposes, procedures, and potential risks of the study and of their rights as 
parent(s) of a research participant. This will take place in a private and 
confidential room. Parents will have the opportunity to carefully review the 
parental permission form, ask questions, discuss the study with others or think 
about it prior to signing. The study team will ask the parent(s) questions about 
the parental permission form to assess comprehension. If the study team feels 
the parent(s) understands what’s being asked of their child, one or both parent(s) 
and study team will sign the parental permission form. Parents will be given a 
signed copy of the parental permission form. Parent(s) will also be instructed that 
they are free to withdraw their permission and discontinue their child’s 
participation in the study at any time. 

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Child’s assent will not be obtained.  Child’s dissent will be honored if parental 
guardian and/or study team member agree that undue harm or distress will be 
placed on the child exhibited through behavior such as crying, tantrum, fit, or 
screaming. 
8-17 years old 
Parent(s) and children interested in hearing more about the study will be 
informed in detail of the purposes, procedures, and potential risks of the study 
and of their rights as parent(s) of a research participant. This will take place in a 
private and confidential room. They will have the opportunity to carefully review 
the parental permission and assent form, ask questions, discuss the study with 
others or think about it prior to signing. The study team will ask questions to 
assess comprehension. If the study team feels the parent(s) understands what’s 
being asked of their child, one or both parent(s) and study team will sign the 
parental permission form. Parents will be given a copy of the signed parental 
permission form. Parent(s) will also be instructed that they are free to withdraw 
their permission and discontinue their child’s participation in the study at any 
time. 
The assent from the child or adolescent will be obtained when this is appropriate 
and when the potential participant is capable of providing assent. The 
determination of appropriateness and capacity of children in the study to provide 
assent is made by the research study member taking into account the ages, 
maturity, and psychological state of the children involved. Child’s dissent will be 
honored. 
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: NA 
21.7 Adults Unable to Consent: NA 
22.0 Setting 
22.1 Research Sites: D2D: The Driven to Discover Research Facility at the Minnesota 
State Fair, August 25-September 5, 2022. 
22.2 International Research: NA 
23.0 Multi-Site Research: NA 
24.0 Coordinating Center Research: NA 
25.0 Resources Available 
25.1 Resources Available:  
The D2D Research Facility at the Minnesota State Fair provides a turn-key research 
space for conduct of minimal risk human subjects research that is appropriate for a 
state fair environment. 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
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Services include: 
• Free admission to the State Fair for staff (up to 4 tickets per shift); 
• Furnishings, basic anthropometric equipment, and supplies; 
• iPads linked to consent forms and survey instruments; 
• U of M secure high-speed wireless and hardwired internet access; 
• Refrigerator and freezer space for on-site sample storage; 
• Guidance in obtaining IRB approval; 
• Consultation on maximizing your recruitment goals, your IRB application, designing 
your research area, working in the state fair setting, and more; 
• Compliance with state fair rules and regulations. 
All persons assisting with the research will be adequately informed about the protocol, the 
research procedures, and their duties and functions.  This information will be shared with 
the researchers prior to the start of the study and the primary investigator will be available 
for any questions relating to the study protocol or procedures at any time throughout the 
study period. 
26.0 References 
1) Schriger DL, Baraff L. Defining normal capillary refill: variation with age, 
sex, and temperature. Ann Emerg Med. September 1988; 17:932-935. 
2) Chameides, L., Ralston, M., American Academy of Pediatrics., & 
American Heart Association. (2011). Pediatric advanced life support. 
Dallas, TX: American Heart Association. 
3) Alsma J, et al. The Power of Flash Mob Research: Conducting a 
Nationwide Observational Clinical Study on Capillary Refill Time in a 
Single Day. Chest. 2017; 115(5):1106-1113.  
4) Jauregui J, Nelson D, Choo E, et al. External Validation and Comparison 
of Three Pediatric Clinical Dehydration Scales. PLoS One. 2014;9(5):1-6. 
doi:10.1371/journal.pone.0095739 
5) Steiner MJ, Dewalt DA, Byerley J. Is This Child Dehydrated ? JAMA. 
2004;291(22):2746-2754. 
6) Shavit I, Brant R, Nijssen-jordan C, Galbraith R, Johnson DW. A Novel 
Imaging Technique to Measure Capillary- Refill Time : Improving 
Diagnostic Accuracy for Dehydration in Young Children With 
Gastroenteritis. Pediatrics. 2006;118:2402-2408. 
doi:10.1542/peds.2006-1108 
7) Gregoski MJ, Mueller M, Vertegel A, et al. Development and Validation 
of a Smartphone Heart Rate Acquisition Application for Health 
Promotion and Wellness Telehealth Applications. International Journal 
of Telemedicine and Applications, vol. 2012, Article ID 696324, 7 pages, 
2012.  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Capillary Refill Time Measurement Utilizing Mobile Application (Cap 
App) in Children 
 
VERSION DATE: 10/27/2022 
 
Page 30 of 30 
Template Revised On: 03/31/2022 
8) Wang EJ, Zhu J, Jain M, et al. Seismo: Blood Pressure Monitoring using 
Built-in Smartphone Accelerometer and Camera. Proceedings of the 
2018 CHI Conference on Human Factors in Computing Systems, April 
2018; Paper No. 425: Pages 1–9.  
9) Wang EJ, Li W, Hawkins D, et al. HemaApp: noninvasive blood screening 
of hemoglobin using smartphone cameras. Proceedings of the 2016 
ACM International Joint Conference on Pervasive and Ubiquitous 
Computing; September 2016: Pages 593–604  
10) Goel M, Wobbrock J, Patel S. GripSense: using built-in sensors to detect 
hand posture and pressure on commodity mobile phones. Proceedings 
of the 25th annual ACM symposium on User interface software and 
technology; October 2012: Pages 545–554  
11) Chamberlain JM, Krug S, Shaw KN, Chamberlain BJM, Krug S, Shaw KN. 
Emergency Care for Children in the United States. Health Aff. 
2013;12(12):2109-2115. doi:10.1377/hlthaff.2013.0871 
12) Alpern ER, Clark AE, Alessandrini EA, et al. Recurrent and High-frequency 
Use of the Emergency Department by Pediatric Patients. Acad Emerg 
Med. 2014;21:365-373. doi:10.1111/acem.12347