REMOTE Study
Research type
Research Study
Full title
A feasibility study to determine if a REMOTE physiological monitoring device can monitor patients following surgery
IRAS ID
181138
Contact name
Ravinder S. Vohra
Contact email
Duration of Study in the UK
0 years, 11 months, 25 days
Research summary
Research Summary
Over five million surgical procedures are performed annually by the NHS. Fifteen percent of patients suffer postoperative complications. These have a major impact on patients and healthcare organisations. It is well established that 40% of patients admitted to the ITU are referred late in the clinical course of their illness due to suboptimal monitoring of physiological parameters including heart rate (HR), respiratory rate (RR) and temperature.
The SensiumVitals patch is a discreet, wearable, wireless, remote monitor which can continuously measures and transmits the HR, RR and axillary temperature every two minutes in ambulatory patients. It is the size of a credit card and sticks to the chest wall at the level of the sternum (breast bone) using a simple widely available electrocardiogram (ECG) electrode. The SensiumVital patch is CE Marked, FDA approved and commercially available.
The aim of this feasibility study is to determine whether the SensiumVitals patch can accurately monitor vital signs in selected patients following major surgery compared to the current in-hospital monitoring they receive (primary aim). In addition, we will assess the durability and acceptability to postoperative patients of the SensiumVitals device to understand the barriers to implementation of such devices (secondary aim). Finally, we will develop methodology to link the transmitted data to existing Electronic Patient Records (secondary aim).
This study will establish the feasibility of performing a phase III study to test the hypothesis that the SensiumVitals patch can identify patients at-risk of postoperative complications before and after discharge following major surgery.
Summary of Results
Title: A feasibility study to determine if a REMOTE physiological monitoring device can monitor patients following surgery. This was a feasibility study undertaken at University Hospitals Birmingham NHS Foundation Trust who also sponsored the study. The initial clinical part of the study took place between November 2015 and May 2016. The study was looking at a new way of recording vital signs such as heart rate and temperature in patients after major surgery. Changes in these signs can be the first indication that the patient is developing complications after surgery, but it takes time for the clinical staff to take and record the measurements. More frequent measurement of vital signs may help with patient management. Sensium have developed a sensor patch to be placed on the patient’s chest that would automatically record vital signs. This study was designed to see if the Sensium patch could measure vital signs accurately enough to be used to alert clinical staff to any changes.
The patch was successfully used on 75 patients to collect their vital signs information after surgery. The patch was only used to record vital signs data, no information was given to the clinical staff and patients were treated exactly as they would have been without the patch. The data was collected and prepared for analysis by a specialist team within the Information Technology department at UHB. The analysis would compare the information collected by the data patch to the data recorded by the usual vital signs monitors to measure the accuracy of the patch. Unfortunately there were unexpected problems with the way the sensor patch data was recorded that made it very difficult to compare the data. Essentially the computer language the two set of records used could not be matched up properly. Several attempts were made between 2016 and 2020 and further work was stopped as priorities changed in response to the COVID-19 pandemic. The primary aim of the study was to determine if the patch could accurately measure vital signs and this could not be confirmed due to the problems with the data recording. A secondary aim was to develop a method for sending information from the patch to the Electronic Patient Record which could not be achieved due to the problems encountered with the systems communicating with each other. No further research is planned until improvements are made with the sensor patch.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0605
Date of REC Opinion
16 Jul 2015
REC opinion
Favourable Opinion