Feasibility of wireless physiological monitoring in infants
Research type
Research Study
Full title
Feasibility of a wireless physiological monitoring and analysis system in newborn infants
IRAS ID
193313
Contact name
Neil Patel
Contact email
Sponsor organisation
Research Co-ordinator, Research and Development, NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
researchregistry2864, http://www.researchregistry.com
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Physiological monitoring is fundamental component of inpatient care in the neonatal unit. Term and preterm neonates receiving intensive and high-dependency care typically have wired monitoring of ECG-derived heart rate and respiratory rate, temperature, peripheral arterial oxygen saturation (SpO2, assessed by pulse oximetry) and arterial blood pressure assessed non-invasively or invasively. \n\nThe Isansys wireless patient monitoring system is designed for wireless continuous physiological monitoring of patients. Non-invasive sensors transmit physiological data using low-energy Bluetooth technology to a local tablet monitor (Patient Gateway) running secure analysis software. Physiological data is analysed and presented as trend data, and is also transmitted to a secure server for centralised storage and future analysis. \n\nThis study will investigate the utility of the Isansys wireless monitoring system in newborn infants. \n\nThe aims of this study are:\n1) To assess agreement of physiological parameters between current neonatal monitoring and the Isansys wireless monitoring system in newborn infants.\n2) To assess staff and parent user experience of the Isansys wireless monitoring system\n3) To investigate the feasibility of collection and analysis of synchronised physiological data for i) calculation of heart rate variability (HRV) and pulse transit time (PTT) and ii) investigation of early patterns of pre-clinical deterioration.\n
REC name
West of Scotland REC 4
REC reference
16/WS/0033
Date of REC Opinion
12 Feb 2016
REC opinion
Favourable Opinion