Assessment of Nightingale Monitors in Healthy Volunteers
Research type
Research Study
Full title
Feasability Assessment of wearable sensors for continuous ambulatory vital signs monitoring. Nightingale, Horizon 2020, phase 2 - validation of early prototypes
IRAS ID
245465
Contact name
David Brealey
Contact email
Sponsor organisation
Universitair Medisch Centrum Utrecht
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 9 months, 15 days
Research summary
Undetected clinical deterioration is a major cause of patient harm on the general hospital ward and potentially at home following hospital discharge. Intermittent (every 6-12hr) vital signs monitoring (blood pressure, heart rate etc) are employed on the ward in an effort to identify and alert clinical teams to deterioration. However this monitoring has changed little over the decades, whilst the patient population has changed dramatically. Patients are now increasingly aggressively managed, frail and elderly, this means deterioration can happen rapidly. A failure to detect, recognise, escalate or act on this deterioration can have a significant impact on morbidity and mortality. An analysis of deaths in hospital in a national database found that “the most common incident types were failure to act on or recognise deterioration” (Donaldson et al, 2014). In the home environment there is essentially no monitoring beyond patient or carer reported events.
The Nightingale project is an EU funded project to stimulate industry to develop novel solutions for this problem (www.nightingale-h2020.eu). Overseen by a consortium made up of experts from 5 European, leading academic medical centres, these solutions aim to be discrete, wearable monitors capable of (semi)continuous monitoring of vital signs both in hospital and at home. They have the capability to transmit this information to the relevant clinical teams (e.g. Critical Care Outreach, Cardiac Arrest Teams) at the relevant time. The consortium has now selected 4 companies to go forward to a prototype stage. These prototypes now need to be tested on healthy volunteers before 2 are selected by the consortium to go forward into the next phase. This observational study aims to test these 4 prototypes in both a home and lab environment to assess usability, acceptability, accuracy of monitoring and transmission of data.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
19/NW/0169
Date of REC Opinion
28 Mar 2019
REC opinion
Favourable Opinion