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

NCT ID: NCT03750318

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Vital Sign; Heart Rate; Respiratory Rate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aingeal

All patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting.

Group Type: EXPERIMENTAL

Vital sign monitoring

Intervention Type: DEVICE

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.

Interventions

Vital sign monitoring

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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 (Heart Rate detection algorithm has not been designed to reject foetal heart rate)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Renew Group

INDUSTRY

Sponsor Role: collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sng Ban Leong

Head and Senior Consultant, Dept of Women's Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ban Leong Sng, FANZCA

Role: STUDY_DIRECTOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018/2223 (Women)

Identifier Type: -

Identifier Source: org_study_id