Condition category
Not Applicable
Date applied
10/05/2019
Date assigned
14/06/2019
Last edited
14/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hospital patients have their vital signs measured regularly. If they are very ill they may need to have them measured continuously. Current monitors are bulky or awkward. This can prevent them from moving and walking enough to help them get better. The Virtual HDU study is aiming to prevent patients from needing this type of monitoring unnecessarily. There are now small wireless vital sign monitors available. In the future we want to put these on hospital patients who are ill but, not ill enough to need standard wired monitors. The monitors may pick up when a patients vitals worsen. It will alert the nurses or doctors to check them and they may give them the treatment they need earlier. This could improve their recovery and could reduce the length of their hospital stay.

Who can participate?
Healthy clinical staff volunteers.

What does the study involve?
This study, Phase 3, involves testing different monitors on a NHS hospital ward to see how they work. This includes checking if the wireless signal is affected by the wards layout. We will test if the monitors are comfortable to wear and easy to use. this will then enable the refinement of the technology before patient testing. They will each wear a monitor for the duration of their shift, when appropriate. They will then complete a questionnaire about wearing the monitor.

What are the possible benefits and risks of participating?
No benefits or risks to participating.

Where is the study run from?
The study will be run by the Critical Care Research Group at the Kadoorie Centre for Critical Care Research and Education.

When is the study starting and how long is it expected to run for?
The study started in April 2019 and will run until the end of August 2019

Who is funding the study?
This study is funded by the NIHR Oxford Biomedical Research Centre.

Who is the main contact?
Louise Young
louise.young@ndcn.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Louise Young

ORCID ID

http://orcid.org/0000-0001-9094-1733

Contact details

Kadoorie Centre for Critical Care Research and Education
Level 3
John Radcliffe Hospitals
Headley Way
Oxford
OX3 9DU
United Kingdom
01865 231482
louise.young@ndcn.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Sponsor (CTRG) and Research and Development ref: 13976

Study information

Scientific title

Virtual HDU Phase 3: locational testing of ambulatory monitoring systems on a surgical ward

Acronym

Virtual HDU Phase 3

Study hypothesis

True continuous vital sign monitoring within the ward environment is not currently feasible due to limitations in vital sign monitoring technology but, is commonly believed to increase the timely detection of patient deterioration. Wearable monitors may provide an alternative continuous monitoring system, affording patients more mobility, less discomfort, reduce nursing time and improve the early detection of abnormal physiological parameters. Barriers to the successful implementation of these wearable devices are reliability, efficiency and data processing systems.

This study aims to demonstrate and test robust a wearable monitoring system with good reliability and reliability, but also be acceptable to end-users of the system.

Ethics approval

Approved 22/02/2019, Medical Sciences Interdivisional Research Ethics Committee, University of Oxford (Research Services, University of Oxford, Wellington Square, Oxford, OX1 2JD; +44(0)1865 616577; +44(0)1865 280467; ethics@medsci.ox.ac.uk), ref: R61573/RE001.

Study design

Observational single-site mixed methods study

Primary study design

Observational

Secondary study design

Mixed methods study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Healthy volunteers

Intervention

This study has been designed to optimise ambulatory monitoring systems to provide reliable continuous data recording in a clinical setting. This will be done during several rounds of testing and troubleshooting, to optimise the systems being tested for clinical use.

Healthy staff volunteers will wear the ambulatory monitor(s) around the target ward for up to the length of a working shift (up to 12 hours). They will wear up to three different combinations of ambulatory monitor. The participants can remove the monitor when needed to undertake direct patient care.

Information regarding the proprtion of time each vital sign parameter is recored versus the time the device was worn. The availability of data collected (via bluetooth and Wi-Fi) will be analysed. The data collection system (software and hardware) will be tested and analysed to detect and troubleshoot and fix errors and improve reliability.

Participants will be asked to complete a questionnaire, rating the user experience of the ambulatory monitors. Study is complete once all participants have worn all of the monitors and completed all questionnaires. There will be no further follow-up.

Intervention type

Device

Phase

Not Applicable

Drug names

N/A

Primary outcome measure

The proportion of time each vital sign parameter (heart rate, SPO2 and breathing rate) is recorded versus time the device is worn.

Secondary outcome measures

1. The frequency and duration of data drop-out for each vital sign parameter.
2. The waveform quality of each vital sign parameter.
3. The wear-ability of the device is measured using questionnaires after each time an ambulatory monitor wear session has ended.
4. The availability of data over the 12 hour period, log of issues and crashes.
5. Duration of battery is measured as life from full charge to battery drain.

Overall trial start date

01/05/2018

Overall trial end date

22/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Staff working for the Oxford University Hospitals NHS Foundation Trust, in the designated area.
2. Willing and able to give informed consent for the study.
3. Aged 18 or over
4. In good health.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Allergies to adhesives dressings or metals e.g. Nickel.
2. Intra-cardiac device e.g. permanent pacemaker (only applicable to the chest patch monitor).

Recruitment start date

17/06/2019

Recruitment end date

22/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way, Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
01865 289885
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://researchsupport.admin.ox.ac.uk/ctrg

Funders

Funder type

Research organisation

Funder name

NIHR Oxford Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

It is anticipated that the study outcome will be used to inform the design of future studies and in the application process for future research.
The project outcome may be written up for peer-reviewed publication with the possibility of being presented in conferences.
The results may be shared internally within the department/university.

We will offer to contact any participants who express an interest in the results of the project.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/06/2019: The recruitment start date was changed from 30/04/2019 to 17/06/2019. 14/05/2019: Trial's existence confirmed by the Medical Sciences Interdivisional Research Ethics Committee.