Vital SignRENEWNCT03750318
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
A study testing Vital sign monitoring in people with Vital Sign and Heart Rate, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Vital Sign, Heart Rate, Respiratory Rate
- What is being tested?
- Vital sign monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Jan 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients, aged 21 years or over
- Patients admitted to post-operative gynaecological ward at KKH Women's and Children's Hospital, Singapore
- Patients receiving opioid therapy via patient controlled analgesia (PCA)
- Patients that are on electronic nursing charting
- Patients that are on acute pain service monitoring
Who cannot join
- 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 (Heart Rate detection algorithm has not been designed to reject foetal heart rate)
Trial locations and contacts
1 site in 1 country.
About this study
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.
Read the detailed description
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 an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.
- Conditions
- Vital Sign, Heart Rate, Respiratory Rate
- Being tested
- Vital sign monitoring
- Keywords
- Vital sign monitoring, Heart rate, Respiratory rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital sign monitoringDevice
Each patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced.
| Study group | Role | What they receive |
|---|---|---|
| Aingeal | Experimental | All patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting. Receives: Device: Vital sign monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Respiratory alarm rate per patient per day
De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.
Measured: 3-4 days (upon admission till 1-3 days after surgery)
Secondary outcomes (3)
Overall Cardiac alarm rate per patient per day
De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.
Measured: 3-4 days (upon admission till 1-3 days after surgery)
False positive Respiratory alarm rate per patient per day
De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.
Measured: 3-4 days (upon admission till 1-3 days after surgery)
False positive Cardiac alarm rate per patient per day
De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.
Measured: 3-4 days (upon admission till 1-3 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start31 Jan 2019
- Primary completion5 May 2019
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Renew Group
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, FANZCA, Study director, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750318
- Sponsor's protocol ID
- 2018/2223 (Women)
- Acronym
- RENEW
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
- ClinicalTrials.gov ID
- NCT03750318
- Acronym / sponsor ID
- RENEW / 2018/2223 (Women)
- Conditions
- Vital Sign, Heart Rate, Respiratory Rate
- Keywords
- Vital sign monitoring, Heart rate, Respiratory rate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Renew Group
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.
Detailed description
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 an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.
| Arm | Type | Receives |
|---|---|---|
| Aingeal | Experimental | Device: Vital sign monitoringAll patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult female patients, aged 21 years or over
- Patients admitted to post-operative gynaecological ward at KKH Women's and Children's Hospital, Singapore
- Patients receiving opioid therapy via patient controlled analgesia (PCA)
- Patients that are on electronic nursing charting
- Patients that are on acute pain service monitoring
Key exclusion criteria (3 listed)
- 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 (Heart Rate detection algorithm has not been designed to reject foetal heart rate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vital sign monitoringEach patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced. | Device | Aingeal |
Primary outcome
Overall Respiratory alarm rate per patient per day
Time frame: 3-4 days (upon admission till 1-3 days after surgery)
De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.
3 secondary outcomes
Overall Cardiac alarm rate per patient per day
Time frame: 3-4 days (upon admission till 1-3 days after surgery)
False positive Respiratory alarm rate per patient per day
Time frame: 3-4 days (upon admission till 1-3 days after surgery)
False positive Cardiac alarm rate per patient per day
Time frame: 3-4 days (upon admission till 1-3 days after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban Leong Sng, FANZCA study director
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital sign monitoring in people with Vital Sign and Heart Rate, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Respiratory alarm rate per patient per day (time frame: 3-4 days (upon admission till 1-3 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.