Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

KK Women's and Children's Hospital

Collaborating Sponsors:

Renew Group

Conditions:

Vital Sign

Heart Rate

Eligibility:

FEMALE

21-70 years

Phase:

NA

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 te...

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 (S...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 31 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2025

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT03750318

Start Date

January 31 2019

End Date

December 31 2025

Last Update

October 9 2024

Active Locations (1)

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KK Women's and Children's Hospital

Singapore, Singapore, 229899