TRaCINg Study
Research type
Research Study
Full title
Trial of Remote Continuous vs Intermittent Vital Signs Monitoring after Major Surgery
IRAS ID
224765
Contact name
Candice Downey
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
Background
Patients having major surgery are at high risk of complications. Identifying complications early makes them easier to treat and improves the results for the patient.
One of the ways patients are monitored for complications is by charting their vital signs: blood pressure, pulse, breathing rate and temperature. A nurse will usually check these signs every four hours in the first few days after surgery. The vital signs form a score, the National Early Warning Score (NEWS), which can detect if the patient becomes unwell. One of the problems with NEWS is that patients can deteriorate in the intervals between monitoring, which can delay vital treatment.
One solution to this problem is continuous monitoring. A wireless patch is worn on the patient’s chest to monitor heart rate, breathing rate and temperature continuously. This could help detect unwell patients earlier.
Aims
In order to test this theory, a study will be done comparing a continuous monitoring system with NEWS monitoring. The research methods will be tested in a small study first, called a feasibility study. The main aim is to provide information about how best to undertake a larger study to fully test the new monitoring system.
Participants
All patients admitted to two participating wards following elective major surgery will be invited to take part.
Methods
Patients who consent will be divided at random to receive standard NEWS monitoring or both the continuous monitoring and NEWS for the duration of their hospital stay.
Information will be collected about the patients’ stay and how patients and nurses feel about the new system. Information will be collected regarding the number of patients who consent, those who do not and their reasons.
Distribution of results
The results will be communicated through journal articles, press releases and presentations to charities, hospitals and the media.
Lay Summary of Results:
Abstract
Background: Up to a third of patients who have major surgery will experience a serious complication, such as infection. Identifying complications early makes them easier to treat and improves the results for the patient. One of the ways patients are monitored for complications is by charting their vital signs: blood pressure, heart rate, breathing rate and temperature. The nurse looking after the patient will usually check these signs every few hours in the days after surgery. The vital signs are used to form a score, the National Early Warning Score (NEWS), which can alert if the patient becomes unwell. One of the problems with NEWS is that patients can become unwell in the interval between monitoring, which can delay vital treatment. One solution to this problem is continuous monitoring. We are testing a wireless monitoring patch that continuously monitors heart rate, breathing rate and temperature. This information is sent wirelessly every two minutes to a mobile phone carried by the nurse, which alerts if the vital signs become abnormal. This could help detect unwell patients earlier than traditional monitoring, but not enough is known about this technology to say for sure. This is why it has to be tested against the current national standard of care: NEWS monitoring. In order to test this theory, we want to do a study comparing the patch system with NEWS monitoring. The main aim of this study is to see whether it is feasible to perform such a study, including whether people will consent to be in the study, whether the monitoring patch can be used in this situation, and how much information we can collect.
Major surgery is dangerous. Complications such as infections can seriously affect a patient’s recovery, and identifying them as early as possible helps to reduce their impact. In order to pick up complications quickly, nurses routinely monitor patients’ vital signs (heart rate, breathing rate, temperature, oxygen levels and blood pressure) at regular intervals. Continuous monitoring might allow complications to be detected even earlier, but until now this has been limited by cumbersome, expensive monitors that tether the patient to their bed and slow their recovery.
Recent advances in wearable technology have heralded the advent of remote wireless monitors. I conducted a feasibility trial of 136 patients who had undergone major surgery. Patients were allocated normal intermittent nurse monitoring (control group) or normal nurse monitoring and a wearable patch that continuously monitored heart rate, breathing rate and temperature (intervention group).
Those that received continuous monitoring had a fewer serious complications, less chance of being admitted to intensive care and a shorter hospital stay when compared to patients receiving intermittent monitoring alone. Patients found the patch comfortable and reported feeling safer whilst wearing it. Economic analyses showed that the patch could be cost-effective by reducing the likelihood of serious complications after major surgery.Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F33292669%252F%2FNBTI%2FZOHFAQ%2FAQ%2F2613c6b2-7825-4572-aa70-7ad29ca81a15%2F2%2FG2eExPK-jG&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C5539258cfc794b49bb1408dec4a0f1b6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639164392692093303%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=IThIUIs9LU2Fw3HwiKI53kbADqVaJD13v4wFcIaoI5Q%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F33292669%252F%2FNBTI%2FZOHFAQ%2FAQ%2F2613c6b2-7825-4572-aa70-7ad29ca81a15%2F2%2FG2eExPK-jG&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C5539258cfc794b49bb1408dec4a0f1b6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639164392692110837%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=AUXCWDKY9kH0QiHYV1uVuLLQpExvr%2B7TuFzxUCy8J3c%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: Participants offered chance to receive results but none accepted.
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Willing to share data on reasonable request. None yet received.
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Not applicable
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Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0180
Date of REC Opinion
28 Jul 2017
REC opinion
Further Information Favourable Opinion