Clinical trial NCT03750318: Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Official title: Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vital Sign
Heart Rate
Respiratory Rate
Keywords: Vital sign monitoring
Heart rate
Respiratory rate
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Renew Group
First posted: 2018-11-23
Enrollment: 39
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Overall Respiratory alarm rate per patient per day
timeFrame: 3-4 days (upon admission till 1-3 days after surgery)
Secondary outcomes:
measure: Overall Cardiac alarm rate per patient per day
timeFrame: 3-4 days (upon admission till 1-3 days after surgery)
measure: False positive Respiratory alarm rate per patient per day
timeFrame: 3-4 days (upon admission till 1-3 days after surgery)
measure: False positive Cardiac alarm rate per patient per day
timeFrame: 3-4 days (upon admission till 1-3 days after surgery)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng, FANZCA
role: STUDY_DIRECTOR
References: