Bodytrak Feasibility Study BT01
Research type
Research Study
Full title
A single group, non-randomised, feasibility study investigating the use of Bodytrak® for post elective surgery patient monitoring in the high dependency unit
IRAS ID
223391
Contact name
Marcela Vizcaychipi
Contact email
Sponsor organisation
Inova Design Solutions Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Ensuring patient safety is challenging since patient deterioration can happen rapidly and go un-noticed. Consequently, the NHS makes use of the National Early Warning System (NEWS) - a vital signs monitoring framework to monitor patients and facilitate early intervention. Currently, the vital signs are obtained manually by staff, which is an error prone and time consuming task. We believe that automating vital signs acquisition for NEWS score calculation is the way forward for the improvement of reliability and efficiency of the care pathway. While some of vital signs can be reliably detected using established sensor platforms, it is more difficult to automate the acqusition of other vital signs reliably, such as the Level of consciousness/alertness (LOC) of the patient. Therefore, one of the objectives of this project is to conduct a feasibility study on the acqusition of the more challenging vital signs by means of Bodytrak®, an unobtrusive and wireless vital signs monitor, designed by Inova Design Solution Ltd, in a post-operative environment. Other objectives include assessing the accuracy of Bodytrak physiological data and collecting patient and nurse feedback. The study will take place at Chelsea and Westminster Hospital (C&W). 8 patients with scheduled elective surgery and aftercare in the high dependency unit (HDU) will be enrolled. Patients will be involved in the study for 2.5 days, which is the typical duration of stay in the HDU at C&W. Each participant will be wearing Bodytrak® during pre and post-operative phases, where body temperature, cardiac related data, and motion metrics (processed information derived from an accelerometer), will be acquired and stored on the device. Along with data collected from existing medical equipment used for patient monitoring, algorithms for measuring LOC, pertinent for tracking patient recovery and deterioration, will be designed through offline retrospective analysis of the data.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0076
Date of REC Opinion
18 Apr 2018
REC opinion
Further Information Favourable Opinion