Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Phase: NA
Conditions: Vital Sign, Heart Rate, Respiratory Rate
Sponsor: KK Women's and Children's Hospital

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STUDY PROTOCOL 
 
 
 
 
Validation study on RENEW’s Aingeal at  
KK Women’s and Children’s Hospital 
 
 
 
 
 
 
 
CRIB NUMBER: 
2018/2223 
 
PROTOCOLL VERSION:  1.0 
 
PROTOCOL DATE:  3 April 2018 
 
 
PRINCIPAL INVESTIGATOR:  
Dr Low Bao Bei Kelly, Associate Consultant, Department of Paediatrics, KK 
Women's and Children's Hospital (KKH)  
 
A/Prof Sng Ban Leong, Senior Consultant, Department of Women’s Anaesthesia, 
KK Women's and Children's Hospital (KKH)  
 
 

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INTRODUCTION 
 
RENEW’s Surveillance Monitoring system is made up of two main components: a patient-worn 
wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software 
platform (Surveillance Station).  
The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin 
temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, 
enabling vital signs trends to be plotted. If any heart, respiration rate or skin temperature values move 
outside of pre-defined high and low limits (individually set for each patient) an alert is raised. ECG 
arrhythmia detection algorithms automatically record and send ECG data if the patient is suspected to 
be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation, Tachycardia or Bradycardia). 
This proposal describes the evaluation of RENEW’s Aingeal device within a paediatric out-patient 
setting in KK Women’s and Children’s Hospital (“KKH”), the main tertiary women and children 
hospital in Singapore.  
In the paediatric population, assessment of RENEW’s Aingeal device will include the accuracy of the 
device at deriving heart rate from single lead ECG and at deriving respiratory rate when compared 
against a commonly used vital signs monitor.  
User acceptance of Aingeal and the Surveillance System will be considered within paediatric settings.  
 
 
AIMS & OBJECTIVES 
The aims of the study are:  
 
To examine the validity of vital signs recorded from paediatric patients (aged between 3 and 
17 years) using the Aingeal device  
 
To determine user acceptance of Aingeal and the Surveillance system 
The study will determine whether:  
1. Heart rates calculated by the Aingeal device during paediatric patient monitoring are within 
clinically acceptable accuracy ranges 
2. Respiration rates calculated by the Aingeal device during paediatric patient monitoring are 
comparable with respiration rates recorded using a portable bedside End Tidal Carbon 
Dioxide (ETCO2)  monitor.   
3. The Aingeal device and Surveillance system are acceptable to Healthcare Professionals 
(HCPs), to paediatric patients, and to paediatric patients’ parents or guardian.  
 
 
 
 
 

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STUDY DESIGN 
Paediatric Out-patient Population 
The Surveillance System will be installed in a paediatric outpatient clinic at KKH. A standalone Wi-Fi 
network will be set up to facilitate system use for the purposes of the study. Children attending the 
clinic aged between 3 and 17 years old will be invited to participate. Written consent from the child’s 
parents or guardian will be obtained prior to participation. 
Subsequent to obtaining consent, trained personnel will confirm the child’s eligibility with their 
parent or guardian against the following inclusion and exclusion criteria: 
Inclusion Criteria 
 Male or female paediatric patients, aged between 3 and 17 years  
 Patients attending outpatient care at KKH Women’s and Children’s Hospital, Singapore 
Exclusion Criteria 
 Patients with active, implantable devices (such as a pacemaker or ICD) 
 Patients with any skin condition or injury affecting the electrode placement site  
 Patients that are pregnant  
 Those patients who, in the opinion of the outpatient clinic staff, are not suitable to participate. 
 
Eligible and willing patients will be set up with an Aingeal electrode and device and Medtronic’s 
Capnostream 35 portable respiratory cannula.   
Recording of vital signs will begin at resting phase with the study subjects seated comfortably for 10 
minutes. Younger children may be seated on the caregiver’s or parents’ lap. After the resting phase, 
the child will be asked to take a short walk around the clinic for 5 minutes. Younger children may be 
offered the playground instead.  
Information on age, height, weight, sex and medical history will be collected from the patients’ 
medical notes or reported by the patient’s parent or guardian. At the completion of vital signs 
recording, feedback from the child and their parents or guardian will be obtained using self-reported 
questionnaires (Appendix 1). 
 
Patient Identification 
A patient enrolment log will be maintained at each investigational site.  This enrolment log will link 
the identifiable patient to a study patient number which will be used on all study data.  
 
Withdrawal and Discontinuation 
All patients will have the right to withdraw their participation from the study at any time.  Withdrawal 
will not affect their routine medical care. Patients may be withdrawn if it is thought to be in their best 
interests. The reason for withdrawal of any patient will be documented and any data gained up to the 
point of withdrawal may be used in analyses. 

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DATA ANALYSIS AND STATISTICAL METHODS 
Paediatric Out-patient Population 
Paediatric patients will be monitored simultaneously using the Aingeal and Capnostream devices for 
fifteen minutes over two phases (ten minutes at rest and five minutes during walking or playing). 
Before data collection commences, the time on the Surveillance Station will be verified against the 
time on the Capnostream device to ensure that respiratory data can be paired as closely as possible.  
Heart Rate Comparison 
Each of the ECG waveforms recorded by the Aingeal device will have heart rate calculated manually 
by a trained reviewer that has been blinded to the heart rate derived by the Aingeal device to minimise 
bias. Ten subjects will provide approximately 100 minutes (or 2 hours) of Aingeal data and 
approximately 100 heart rates. Both sets of heart rates will be compared using the approach of Bland 
Altman [1, 2].  
Respiratory Rate Comparison 
The Aingeal device averages respiration rate over a 30 second window (or a period of 10 breaths, 
whichever is shorter). The respiration rate is updated each minute at the Surveillance Station. The 
Capnostream device stores data at resolution of 1 sample per second.  
As a result there will be many more data points from the Capnostream device than from the Aingeal 
device over the same observation period. Ten subjects will provide approximately 100 minutes (or 2 
hours) of Aingeal data and approximately 100 respiration rates. Both sets of respiratory rates will be 
compared using the approach of Bland Altman. Datasets will be stratified by age group as described 
in Table 1.   
A total sample of 10 paediatric outpatients stratified by the age groups of 3 to 5 years old, 6 to 9 years 
old, 10 to 14 years old and 15 to 17 years old is estimated to provide an accuracy of 5% for respiratory 
rate, with estimated differences ranging from 0.7 to 1.25 breaths. The sample estimation is calculated 
based on a minimum of 8 repeated measures per child, having accounted for 20% attrition rate and 20% 
data loss due to signal loss, noise or time discrepancies. 
Bland Altman Analysis 
The heart and respiration rate counts from each measurement method will be compared against each 
other in a pair-wise manner using the approach of Bland & Altman.   For each parameter, this 
involves plotting the difference in the counts against the mean of the two absolute counts.  The 95% 
and 99% limits of agreement, equivalent to 2 times standard deviation (sd) and 3 sd will be plotted. 
This process will be repeated for each portion of the test (at rest and during activity) and for each age 
group (3 to 5 years old, 6 to 9 years old, 10 to 14 years old and 15 to 17 years old) for heart rate and 
respiration rate. Adjustments for age and sex will be considered.  
Feedback and Demographic Analysis 
Summaries of patient, parent and HCP acceptability, demographics and medical history will be 
produced.   In general, categorical data will be summarised using frequency counts and percentages, 
and continuous data will be summarised using means, standard deviations, minimums, medians and 
maximums. 
 
 
 

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RENEW’s AINGEAL PROCESS REQUIREMENTS   
 
A. Application and Registration  
 
No  Step by Step Application 
1 
Add patient to Central (Surveillance) Station. 
2 
Assign Aingeal Device to patient.  
(Pair the RENEW’s Aingeal Device identifier code with Subject ID on the Surveillance 
Station and on the Patient Log.  .) 
3 
Thoroughly clean the skin using alcohol wipes. Poor skin prep may result in poor signal 
quality.  
4 
Apply electrodes: Position the electrodes as shown in the figures below. RENEW’s 
Aingeal Device should be placed on the left chest, just left of the centre of the sternum and 
below the collar bone. The right chest electrode should be placed just right of the centre of 
the sternum and below the collar bone. Place the electrode on the left side of the patient’s 
body at the 7th rib and on the midline. 
5 
Connect device & start-up: Turn on RENEW’s Aingeal device by pressing the “ON” 
Button. Check that the device beeps, that the Wi-Fi LED changes from orange to green, 
and that the Leads LED changes from blue to unlit.  
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Start Monitoring Patients on RENEW’s Surveillance Station. Validate waveforms. 
7 
Check alarm limits. 
 
 
 
 
 
 
 
Fig. A. Aingeal Device on adult  
 
 
 
B. Data Collection and Validation  
The RENEW’s Aingeal is a wearable wireless device that measures single lead ECG and 
impedance pneumography waveforms to derive heart and respiration rates. Skin temperature is 
measured via a thermistor on the electrode patch. Every minute these parameters and a 25 second 
snapshot of waveform data are transmitted to the Surveillance Station over Wi-Fi.  
The RENEW’s Aingeal will be attached onto the Subjects for continuous monitoring during the 
Study. 
i. 
The Subjects will each be identified by a unique Subject ID assigned at time of 
recruitment and a Device ID using an agreed format. 
 
ii. 
Raw vital signs data ie. Readings, will be extracted from Surveillance System and 
provided to KKH research team for further study data mapping and analysis. 

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iii. 
Sampling Rate will be derived using a data averaging method over a period of 60 
seconds for the Capnostream data output. KKH requires all raw data points, in 
additional to per minute. 
 
iv. 
KKH will extract the averaging data points for further data processing and mapping 
against the Subject’s demographics; e.g age, gender, height, weight etc. 
 
For first week of the trial, Renew is required to extract the daily data files onsite and provide 
to KKH. This is to ensure that the setup is working well and correct data is collected and 
verified. There is no contact between the participants and the representative from the study 
sponsor. Also, the patient’s details will not be keyed into the system as we will only put 
participant’s subject ID number, which will not allow sponsor to identify the patients. 
Removal and De-Registration 
 
No  
Step by Step Application 
1 
Turn off the RENEW’s Aingeal by pressing and holding the “OFF” Button on the 
RENEW’s Aingeal until the green LED is unlit. 
2 
Remove the RENEW’s Aingeal gently from the Subject 
3 
Slowly and carefully remove the electrodes from the Subject 
4 
The subject can be discharged from the Surveillance Station after data collection has 
completed and all required data is collected. 
5 
Dispose the electrodes appropriately into designated bins. 
 
C. Training Plan 
The training program is designed to provide the relevant study team members with sufficient 
knowledge and skills to configure and use the RENEW Surveillance System. The program will 
comprise of interactive instructor led clinical demonstration. 
Training will take place onsite. The study team members are encouraged to actively participate in 
the demonstration cum hands-on session. This is to prepare the study team members to 
understand and identify any potential modifications being made to their existing routines and 
workflow. 
 
ROLES AND RESPONSIBILITIES  
RENEW will provide all necessary Surveillance system equipment and accessories required to 
facilitate validation of the Aingeal Surveillance system. KKH’s involvement includes proposal 
development and data collection for the paediatric study and for the adult in-patient study, analysis 
and reporting of study findings will be performed additionally. KKH will also be providing space and 
technical support necessary for the conduct of the validation study. 
 
 

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TIMELINES AND DELIVERABLES 
Stages 
Period 
Planning  
July 2017 to October 2017 
HSA approval for Aingeal 
Dec 2017 
IRB submission to approval 
Jan 2018  
Internal briefing 
Jan 2018 
Commencement of study 
Jan 2018 
Mid-study interim report   
Apr 2018 
Completion of study    
June 2018 
Data collation and analysis 
July/August 2018 
Findings (Dissemination) 
September 2018 
Publication of study 
December 2018 
 
 
CONCLUSION 
This study is aimed to test the feasibility of RENEW’s Aingeal in a clinical setting, and its findings 
may be useful in augmenting RENEW’s Aingeal system’s role in clinical monitoring of vital signs 
and early warning system for paediatric patients at KK Women’s and Children’s hospital.  
 
References 
1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of 
clinical measurement. Lancet (London, England) 1986;1(8476):307-10 
2. Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against 
standard method is misleading. The Lancet 1995;346(8982):1085-87 doi: 
http://dx.doi.org/10.1016/S0140-6736(95)91748-9[published Online First: Epub Date]|. 
 
 

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Appendix 1 
Date:  
 
        Questionnaire for Healthcare Staff 
1. Did you receive any briefing in how to use the RENEW's Aingeal device? 
 
     Yes 
    No            Not Sure 
2. Was the information given to you adequate? 
      Yes 
   No            Not Sure 
 
Please answer all the questions that apply to your duties. If a 
question does not apply to your responsibilities, please select Not 
Applicable. Take note that there is no right or wrong answer. 
 
Additional comments 
 
   
During the test of RENEW's Aingeal Device: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Not 
Applicable 
It was easy to set patients up on the 
Surveillance Monitoring Central Station. 
1 
2 
3 
4 
5 
9 
RENEW's Aingeal Device was easy to apply 
onto 
the patient. 
1 
2 
3 
4 
5 
9 
RENEW's Aingeal Device did not 
appear to increase patient's discomfort. 
1 
2 
3 
4 
5 
9 
Loss of readings (vital signs) from 
RENEW's Aingeal Device was 
uncommon. 
1 
2 
3 
4 
5 
9 
I was able to view and monitor my patient's 
vital signs on the Surveillance Monitoring 
Central Station easily. 
1 
2 
3 
4 
5 
9 
I could have used RENEW's Aingeal Device 
without special training. 
1 
2 
3 
4 
5 
9 
RENEW's Aingeal Device meets my clinical 
needs. 
1 
2 
3 
4 
5 
9 
RENEW's Aingeal Device is safe for clinical 
use. 
1 
2 
3 
4 
5 
9 
RENEW's Aingeal Device Surveillance 
Monitoring is easily integrated with the ward 
routine. 
 
 
 
 
 
 
RENEW's Aingeal Device Surveillance 
Monitoring enhances patient care delivered in 
the ward. 
1 
2 
3 
4 
5 
9 

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Questionnaire for Participants (Paediatric outpatient clinic) 
 
 
Date:  
 
  
 
Ward:  
 
 
Please answer all questions. Parents/Accompanying adults involved may provide assistance to children in 
responding to this survey. Take note that there is no right or wrong answer. 
 
During the test of RENEW's Aingeal Device: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
I was given adequate information on the 
RENEW's Aingeal Device to be used on my 
child/ward. 
1 
2 
3 
4 
5 
My child/ward is comfortable having 
RENEW's Aingeal Device on him/her all the 
time. 
1 
2 
3 
4 
5 
My child/ward does not have skin irritations 
from using RENEW's Aingeal Device. 
1 
2 
3 
4 
5 
My child/ward is able to continue with 
his/her daily activities with RENEW's 
Aingeal Device. 
1 
2 
3 
4 
5 
My child/ward is comfortable having his/her 
heart and respiratory rates monitored using 
RENEW's Aingeal Device. 
1 
2 
3 
4 
5 
If my child’s vital signs need to be monitored 
for medical reasons, I would feel more secure 
with continuous monitoring of my child’s 
heart and respiratory rates using RENEW's 
Aingeal Device than with periodic checks by 
hospital staff or nurses. 
1 
2 
3 
4 
5 
 
 
Additional comments