Vital SignNCT03754231
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
A study testing Heart rate monitoring and Respiratory rate 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 in a paediatric outpatient population in 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 3 to 17 years
- Conditions the study is for
- Vital Sign, Heart Rate, Respiratory Rate
- What is being tested?
- Heart rate monitoring and Respiratory rate monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Jan 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female paediatric patients, aged between 3 and 17 years
- Patients attending outpatient care at KK Women's and Children's Hospital, Singapore
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
- Those patients who, in the opinion of the clinic staff, are not suitable to participate.
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 in a paediatric outpatient population in 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. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population 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 the clinical settings.
- Conditions
- Vital Sign, Heart Rate, Respiratory Rate
- Being tested
- Heart rate monitoring, Respiratory rate 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.
Heart rate monitoringOther
The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:
- 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing
Respiratory rate monitoringOther
The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:
- 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing
| Study group | Role | What they receive |
|---|---|---|
| Aingeal | Experimental | All recruited patients will wear the Aingeal device as a form of heart rate monitoring and respiratory rate monitoring in a paediatric outpatient clinic setting. Receives: Other: Heart rate monitoring; Other: Respiratory rate monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate comparison
Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach
Measured: 15 minutes
Secondary outcomes (1)
Respiratory rate comparison
Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start30 Jan 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
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 at a paediatric outpatient clinic setting.
- Masking
- None (open label)
- Enrolment
- 10 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, Low Bao Bei Kelly, KK Women's and Children's Hospital
- Investigators
- Bao Bei Kelly Low, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754231
- Sponsor's protocol ID
- 2018/2223 (Paediatric)
- Status last verified
- Mar 2022
- First submitted
- 21 Nov 2018
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. 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
- NCT03754231
- Acronym / sponsor ID
- 2018/2223 (Paediatric)
- Conditions
- Vital Sign, Heart Rate, Respiratory Rate
- Keywords
- Vital sign monitoring, Heart rate, Respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Renew Group
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 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 in a paediatric outpatient population in 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. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population 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 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 at a paediatric outpatient clinic setting.
| Arm | Type | Receives |
|---|---|---|
| Aingeal | Experimental | Other: Heart rate monitoring, Other: Respiratory rate monitoringAll recruited patients will wear the Aingeal device as a form of heart rate monitoring and respiratory rate monitoring in a paediatric outpatient clinic setting. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female paediatric patients, aged between 3 and 17 years
- Patients attending outpatient care at KK Women's and Children's Hospital, Singapore
Key exclusion criteria (4 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
- Those patients who, in the opinion of the clinic staff, are not suitable to participate.
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 |
|---|---|---|
| Heart rate monitoringThe heart rate of recruited patients will be monitored for 15 minutes over 2 phases: i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing | Other | Aingeal |
| Respiratory rate monitoringThe heart rate of recruited patients will be monitored for 15 minutes over 2 phases: i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing | Other | Aingeal |
Primary outcome
Heart rate comparison
Time frame: 15 minutes
Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach
1 secondary outcome
Respiratory rate comparison
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Bao Bei Kelly Low principal investigator
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 Heart rate monitoring and Respiratory rate 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate comparison (time frame: 15 minutes). 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 31 Mar 2022.