Condition category
Surgery
Date applied
15/12/2016
Date assigned
19/12/2016
Last edited
23/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients having surgery are at high risk of complications, some of which can be life threatening. Identifying complications early makes them easier to treat and improves the outcome 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 four hours in the days after surgery. They are used to form the National Early Warning Score (NEWS), which can alert if the patient becomes unwell. One of the problems with NEWS is that patients can deteriorate in the interval between monitoring, which can delay vital treatment. This study is looking at a monitoring system that measures heart rate, breathing rate and temperature continuously. It is a wearable, wireless patch that is applied to the patient's chest and alerts the nurse if the patient's vital signs become abnormal. This could help detect unwell patients earlier than NEWS monitoring. The aim of this study is to find out whether this monitoring system is a feasible and effective way of monitoring surgical patients and if using it can improve patient outcomes.

Who can participate?
Adult patients admitted to participating surgical wards.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the continuous monitoring alongside standard NEWS monitoring. Those in the second group receive standard NEWS monitoring alone. Patients are followed up during their hospital stay to see if any complications occur and how quickly they are detected until they are discharged from hospital.

What are the possible benefits and risks of participating?
The potential benefit of receiving a monitoring patch is closer monitoring during the patient's hospital stay. Any risks are likely to be small, but will be monitored throughout the study.

Where is the study run from?
St James's University Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2015 to July 2017

Who is funding the study?
Health Foundation (UK)

Who is the main contact?
Miss Candice Downey
c.l.downey@leeds.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Candice Downey

ORCID ID

http://orcid.org/0000-0001-9818-8002

Contact details

University of Leeds
Level 7 Clinical Sciences Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 113 243 1751
c.l.downey@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32955

Study information

Scientific title

An evaluation of remote, near-continuous vital signs monitoring in patients admitted to surgical wards

Acronym

Study hypothesis

The aim of this study is to evaluate whether continuous remote vital signs monitoring is a feasible and effective way of monitoring surgical patients and if its use improves patient outcomes.

Ethics approval

Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 30/11/2016, ref: 16/YH/0426

Study design

Randomised; Interventional; Design type: Diagnosis, Prevention, Device, Management of Care, Surgery, Active Monitoring

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Surgery, Primary sub-specialty: Other; UKCRC code/ Disease: Other/ General symptoms and signs

Intervention

Patients will be pseudo-randomised to either study arm according to which bay they are admitted into on the participating wards.

Patch bays: Patients will receive SensiumVitals monitoring and usual National Early Warning Score (NEWS) monitoring.
Non-patch bays: Patients will receive NEWS monitoring alone.

Patients will be approached when they are admitted to the participating wards. They will remain in the study arm to which they are allocated for the duration of their stay on the participating wards. On discharge from hospital, their participation in the trial will be over.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Time to antibiotics in patients who are diagnosed as suffering from sepsis is measured by review of the observations chart, the SensiumVitals data, the electronic medications record and the medical notes of the patient during their hospital admission.

Secondary outcome measures

1. In-hospital mortality is measured by review of the patient's medical notes at the point of discharge
2. Length of hospital stay is measured by review of the patient's medical notes at the point of discharge
3. Number of admissions to Level II/III care is measured by review of the patient's medical notes at the point of discharge
4. Length of stay at Level II/III is measured by review of the patient's medical notes at the point of discharge
5. Patient satisfaction is assessed by questionnaire and/or structured interview on discharge
6. Staff satisfaction is assessed by questionnaire and/or structured interview at a time convenient for the participant and at least 2 months after the commencement of recruitment

Overall trial start date

05/09/2015

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients admitted to one of the participating wards
2. Aged 18 years or over
3. Able to provide informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 500; UK Sample Size: 500

Participant exclusion criteria

1. Those who do not consent
2. Allergy to adhesives on electrodes
3. Cardiac pacemaker in situ

Recruitment start date

09/12/2016

Recruitment end date

26/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
-
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

-
Leeds
LS2 9JT
United Kingdom
+44 113 34 37587
governance-ethics@leeds.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This research has already been presented at the Extreme Medicine Conference (London, October 2015) and as a piece on the BBC’s One Show.
Other dissemination plans, at the end of the project, include:
1. Presentation to the Trust Clinical Governance Board.
2. Presentations at local and national clinical meetings to disseminate the findings.
3. Publication of the study in a peer-reviewed journal e.g. British Journal of Surgery, likely December 2017
4. Dissemination through the NIHR HTC in Colorectal Therapies network with reach to healthcare workers throughout the NHS
5. Engagement with NIHR Local Clinical Research Networks
6. Engagement with professional bodies (Association of Coloproctology of GB&I, Association of Surgeons of GB&I, British Association of Nursing etc.) to inform relevant healthcare workers
7. Use of existing patient and public forums (e.g. Bowel Cancer UK, Crohn’s and Colitis Association) to inform the wider public
8. Engagement of media outlets, including the Trust Press Office, and local and national news agencies

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Miss Candice Downey (c.l.downey@leeds.ac.uk)

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes