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

NCT03754231 | Completed

• 1 other identifier: 2018/2223 (Paediatric)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Sign; Heart Rate; Respiratory Rate

Keywords

Vital sign monitoring; Heart rate; Respiratory rate

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Respiratory rate comparison

  15 minutes

Study Arms (1)

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

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

Aingeal

Respiratory 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

Aingeal

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female paediatric patients, aged between 3 and 17 years
• Patients attending outpatient care at KK Women's and Children's Hospital, Singapore

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Renew Group: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Study Officials

• Bao Bei Kelly Low

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Department of Paediatrics

Model Details: All patients recruited will be wearing the Aingeal device at a paediatric outpatient clinic setting.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: January 30, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)