Validation Study on RENEW's Aingeal at KK Women's and Chi... | NCT03754231

Studies
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

NCT03754231

Sponsor

KK Women's and Children's Hospital

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Vital Sign
Heart Rate
Respiratory Rate

Interventions

Heart rate monitoring
Respiratory rate monitoring

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2018Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Nov 21, 2018

First Submission Date that Met QC Criteria

Nov 23, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Mar 31, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Low Bao Bei Kelly, Associate Consultant, Department of Paediatrics, KK Women's and Children's HospitalPrincipal Investigator

Lead Sponsor

KK Women's and Children's HospitalOTHER_GOV

Collaborators

Name	Class
Renew Group	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Heart rate monitoring Other: Respiratory rate monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heart rate monitoring	Other	The 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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate comparison	Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach	15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Respiratory rate comparison	Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.	15 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female paediatric patients, aged between 3 and 17 years
Patients attending outpatient care at KK 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 clinic staff, are not suitable to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bao Bei Kelly Low	KK Women's and Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KK Women's and Children's Hospital		Singapore		229899	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided