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

NCT03750318 | Active Not Recruiting

• 1 other identifier: 2018/2223 (Women)
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Sign; Heart Rate; Respiratory Rate

Keywords

Vital sign monitoring; Heart rate; Respiratory rate

Outcome Measures

Primary Outcomes (1)

• Overall Respiratory alarm rate per patient per day

  De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.

  3-4 days (upon admission till 1-3 days after surgery)

Secondary Outcomes (3)

• Overall Cardiac alarm rate per patient per day

  3-4 days (upon admission till 1-3 days after surgery)

• False positive Respiratory alarm rate per patient per day

  3-4 days (upon admission till 1-3 days after surgery)

• False positive Cardiac alarm rate per patient per day

  3-4 days (upon admission till 1-3 days after surgery)

Study Arms (1)

Aingeal

EXPERIMENTAL

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

Device: Vital sign monitoring

Interventions

Vital sign monitoring 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.

Aingeal

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Only women receiving gynaecological surgery in the mentioned hospital will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

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

• Ban Leong Sng, FANZCA

  KK Women's and Children's Hospital

  STUDY DIRECTOR

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: Head and Senior Consultant, Dept of Women's Anaesthesia

Model Details: All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: January 31, 2019
• Primary Completion: May 5, 2019
• Study Completion: December 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)