Active, Not Recruiting

NCT Number: NCT03750318

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Vital Sign Heart Rate Respiratory Rate

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Overall Respiratory alarm rate per patient per day

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

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.

Secondary outcomes

Overall Cardiac alarm rate per patient per day

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

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

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

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 False Positive Alarm Rate per patient per day derived.
False positive Cardiac alarm rate per patient per day

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

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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

Renew Group

Registry information

Acronym: RENEW

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2025
First posted: Nov 23, 2018
Registry last updated: Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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