Remote patient monitoring for preoperative risk assessment
Research type
Research Study
Full title
REMOTES Study REmote Monitoring for preOperaTive risk assEssment for major abdominal Surgery
IRAS ID
307403
Contact name
David Jayne
Contact email
Sponsor organisation
The Secretariat, The University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 25 days
Research summary
Summary of Research
Preoperative risk assessment (an evaluation of overall health before surgery) is important to determine the overall risk of mortality and complications for patients undergoing major abdominal surgery, to allow appropriate allocation of sparse hospital resources. The current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET). CPET is however not available in all centres that perform major surgery, is a costly test and therefore only high-risk patients are tested. Finding new ways of conducting preoperative assessment could improve overall surgical safety, patient experience and reduce cost.
The use of remote vital signs monitoring preoperatively can provide important information about the patients' fitness and overall health and may possibly be used for preoperative assessment. This study will use a remote monitoring patch to monitor patients' vital signs before surgery. The study will evaluate the utility and patient acceptability of the remote monitoring system and the feasibility of a randomised controlled trial of this type of assessment. Additionally the study will assess the correlation between the data captured by the remote monitoring system and the CPET results, in order to evaluate the remote monitoring systems ability to predict risk of surgery.
The study will take place in Leeds Teaching hospitals. Adult patients undergoing major abdominal surgery that require CPET before surgery are eligible. Participants will be monitored at home with the patch monitor for 3-5 days before surgery, in addition to their planned preoperative assessment. During remote monitoring patients will be asked to fill out questionnaires on their general health and their experience of using the patch through the mobile phone that is used as a part of the monitoring system. Clinical data from the hospital electronic records and general practitioner records available on the trust system will then be collected at 30 days after surgery to assess complications and to calculate risk scores.Summary of Results
Understanding the problem
Major abdominal surgery can be lifesaving but carries a high risk of complications, affecting up to 50% of patients. While those at the highest risk make up a small proportion of the surgical patients, they account for more than 80% of those who experience complications. The number of these high-risk patients is set to increase over the coming years, particularly as the population ages.
Doctors currently use an exercise test to assess whether patients are fit for surgery. This test involves cycling up to maximum effort on an exercise bike while measuring heart and lung function. While this is the best available method at present, it does come with drawbacks. For many vulnerable and frail patients, the test is a major challenge, and they are often unable to perform it. Therefore, no useful information are provided to the surgical teams to decide on how risky the surgery would be for the patient.
Digital technology in the form of a wearable device could be potentially helpful in helping doctors assess patients. Wearable devices have been used to monitor patients in the recovery period with promising findings, but their use in the preoperative period has not been evaluated yet. Smartwatches and fitness trackers have the potential to capture heart and activity information over a longer period of time that could prove very useful in understanding someone’s fitness without requiring the exhaustive exercise cycling test.This piece of research aims to explore whether wearable technology in the form of a medical wearable device can be used safely and effectively to assess a patient’s fitness for surgery. The study also examines how acceptable this approach is to both patients and healthcare professionals. Participants scheduled for bowel surgery are invited to participate and wear the wearable monitor before surgery takes place for three to five days. At this stage, the study will not provide additional information for the doctors to make decisions for patients. Our goal is to use the data from the wearable device to train advanced algorithms with the help of artificial intelligence, to identify those at high risk for surgery in the future.
Results:
A total of 198 patients were enrolled with a mean age of 68.7 years. Recruitment to the study exceeded initial expectations. The uptake was encouraging with an overall consent rate reaching 60% among those approached by the research team (n=331).
Feedback from participants
The study was generally well received by patients of all age groups [range 25-94]. Participants have embraced the concept of remote at-home monitoring. They felt empowered by being involved in their healthcare and reassured by the enhanced level of monitoring. Participants have reported that this way of assessment could detect “hidden or unknown problems” and help to “reduce stress offer more peace of mind”.
They also reported that they found the system easy to understand and use, and generally less burdensome compared to CPET. Some were enthusiastic about the technology which makes the recruitment process easier for the research team. Patients, also seemed to share the same vision with the research team in that this way of assessing fitness is more inclusive; it can be applied to everyone, even to patients that cannot exercise, overcoming a major CPET drawback.
Some of our older patients, although initially sceptical about the technology, reported later that they felt they had enough support from the research team to sort out any problems that they encountered during the monitoring period and found the system overall easy to operate. Almost all patients reported that they would wear a similar device again for medical reasons and only two suggested that they would wear one if some improvements on the system were made.
Participants wore the device for a mean of 72.5h. Following data analysis, wear-time attained was deemed satisfactory with 83.3% of participants achieving approximately the 72h requirement with an allowance of a six-hour window of the intended target.
One patient reported a topical allergy related to the adhesive of the wearable device, which has been documented as an adverse event and reported to the sponsor.Continuous skin contact is essential for the ECG electrodes integrated in the wearable device to reliably capture heart activity. Adhesion issues were recorded during the monitoring period and classified according to severity with 18% of participants experiencing problems of variable significance. On seven occasions, major issues were observed with the device falling off, compromising therefore the data quality.
Disconnections were a frequent occurrence throughout the trial and observed in almost all participants leading to missing data. Despite the above, when analysing data, we noted only around 10% mean missingness overall with ECG data missing more frequently likely due to a combination of adhesion and connection issues as seen on the graph below.
Support
It was evident in the study that participants required some form of remote support due to disconnections observed by the research team during the monitoring period. Overall, 55% of participants required technical support which proved crucial throughout the study to ensure the continuity and accuracy of physiological data being transmitted, although in most of the cases this was in the form of an alert to the participant to check their connection, and only five participants had major issues that resulted in cessation of the monitoring session.
Overall, it seems that remote patient monitoring for preoperative risk assessment is feasible and desirable for patients but a good level of systematic support to patients will be required to enable this in the NHS.REC name
South East Scotland REC 02
REC reference
22/SS/0050
Date of REC Opinion
30 Aug 2022
REC opinion
Further Information Favourable Opinion