HRV
Research type
Research Study
Full title
Pilot Study investigating Heart Rate Variability as a predictor of Post Operative Complications in patients undergoing elective major colorectal surgery
IRAS ID
247972
Contact name
Anton Krige
Contact email
Sponsor organisation
East Lancashire Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study aims to investigate the practicality and benefits of monitoring a patient's Heart Rate Variability (the change in the gap between heartbeats over time) as a potential new method for identifying those who are developing complications following elective (planned) bowel surgery.
Reductions in Heart Rate Variability (HRV) have been shown by a growing body of evidence to correlate with developing or impending heart dysfunction, inflammation associated with sepsis and respiratory failure (lung problems) – all of which can occur as complications of major bowel surgery. The current gold standard of monitoring complication development is done by measuring the National Early Warning Score (NEWS score, a numerical score based on a patient’s vital signs – heart rate, breathing rate, blood pressure, etc) and postoperative blood. NEWS alerts healthcare staff to a potentially deteriorating/worsening patient but it takes some time to display a trend of change with deterioration and requires intensive regular nursing interventions from every fifteen minutes to four hours (eg taking blood pressure hourly) which are also disruptive for patients. Developing a passive method for identifying deteriorating patients would thus benefit patients by being less disruptive and potentially leading to earlier interventions to treat developing problems.
Patients who consent to this study in Royal Blackburn Hospital will wear a single small self-adhesive wearable sensor patch (Isansys Lifetouch sensor patch) detecting HRV data on their chests in the hospital and have a follow-up telephone conversation at home thirty days after the surgery. A recording monitor approximately the size of a tablet will accompany them in the hospital and will record their HRV data. All data will be stored as anonymised files which will automatically be uploaded by the monitor to an online secure server on the hospital network. Data will not be transmitted over the internet, and the devices are secured against unauthorised access attempts.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0007
Date of REC Opinion
19 Jan 2023
REC opinion
Favourable Opinion