Enhanced Monitoring Using Sensors After Surgery (EMUs)
Research type
Research Study
Full title
Enhanced Monitoring Using Sensors After Surgery (EMUs) - Continuous physiological monitoring for the detection of postoperative patient deterioration: A Multi-stage Study
IRAS ID
332982
Contact name
Ewen Harrison
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
The failure to detect and intervene upon commonly occurring complications after surgery results in avoidable morbidity and mortality. This is termed failure to rescue. While patient and disease factors partially explain avoidable death after surgery, health system factors such as the use of postoperative monitoring, emergent imaging, and critical care facilities are key to rescuing patients from major complications.
Death following surgery is due to bleeding, sepsis, or a myocardial injury in almost half of instances. Prompt identification and management of these complications promises reductions in avoidable mortality. Failure to recognise deterioration in a timely manner is common. Close monitoring in the early postoperative period is important, given the median time from surgery to major bleeding (day of surgery, interquartile range 0–2), myocardial injury (day 1, IQR 0–1) and sepsis (day 6, IQR 3–11).
Continuous postoperative monitoring using “wearable” devices could provide early alerts of deterioration to clinical teams allowing prompt management of serious complications. Integrating raw physiological monitoring data including heart rate, respiratory rate, peripheral oxygen saturation (SpO2), pule arrival time, skin temperature, and movement has potential. However, no validated algorithm currently exists linking these data with patient outcomes or decision cues for healthcare teams. Indeed, a recent scoping review showed studies in this area were limited by recruited patient numbers (N = 10 to 51) and methods employed. There are no on-going largescale studies gathering multimodal waveform data and patient outcomes in the postoperative surgery period to determine the utility of this approach. This study seeks to do so.This study has three objectives which will be addressed in three stages.
STAGE 1. Usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment.
STAGE 2. Baseline postoperative monitoring practice assessment and device usability testing in clinical environment.
STAGE 3. Shadow-mode cohort study with collection of time-stamped sensor and clinical event data to determine relationships between physiological waveforms and patient deterioration.REC name
West of Scotland REC 5
REC reference
23/WS/0168
Date of REC Opinion
22 Nov 2023
REC opinion
Favourable Opinion