SurgeryvHDU phase 5NCT05118477
vHDU Phase 5: Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes
A study testing Ambulatory monitoring system and Active alerting system in people with Surgery and Deterioration, Clinical, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Sometimes in hospital, it is not noticed that patients are becoming unwell quickly enough. This may mean that they are less likely to survive than if the worsening of their illness had been picked up sooner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Deterioration, Clinical
- What is being tested?
- Ambulatory monitoring system and Active alerting system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jul 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient stable for at least 6 hours with at least one of the following:
- NEWS2 <= 2 and (in some exceptional NEWS >2 confirmed with clinical staff, eg. patients with comorbidities).
- Frequency of observations of >4 hours at the time of randomisation.
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Any patient admitted to the participating surgical unit (including post-ICU patients) who are not currently monitored with standard continuous monitoring
Who cannot join
- The participant may not enter the trial if ANY of the following apply:
- Intra-cardiac device
- Monitored for less than 24 hours
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals Trust
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: The Virtual High Dependency Unit (vHDU) Project Phase 5: Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes. A Feasibility Randomised Controlled Trial
Sometimes in hospital, it is not noticed that patients are becoming unwell quickly enough. This may mean that they are less likely to survive than if the worsening of their illness had been picked up sooner. One reason for this may be that hospital staff are unable to check patients' vital signs (such as breathing rate, heart rate and level of oxygen in their blood) frequently enough to help them decide if a patient is becoming more unwell. Currently, for nurses to watch these vital signs closely, patients are either attached to a static machine by the patient's bedside using wires, or staff visit the patient every few hours to measure these vital signs using a portable wired machine. It is now possible to closely monitor patients using small devices which attach to the wrist, finger or chest. These devices allow nursing staff to continually watch vital signs data from these patients when they are away from their bedside. These machines are also wireless and portable, so they do not stop patients moving around, which is important for recovery, and are comfortable to wear. In past years, the investigators have tested these devices and developed a system to allow the clinical staff to see the continuous vital signs. In this final stage of the project, the investigators will test this system (with the selected devices) on patients in hospital. The investigators will start by doing a small trial on one surgical ward, and asking for staff and patient feedback of how the system worked, how useful it was, and how easy to use. If the feedback from this first small trial is positive, the investigators will conduct a future trial in several hospitals, to test how useful the system is in improving patient recovery.
Read the detailed description
The primary objective of this study is to assess the impact of ambulatory monitoring systems (AMS) integration (with active clinical alerts) versus standard care in deterioration detection.
Secondary objectives include other deterioration detection and clinical outcomes, trial progression outcomes, staff impact and alerting system performance, overall system reliability and patient experience.
This study is a superiority feasibility randomised controlled trial with two-arm parallel groups and 1:1 allocation ratio to compare the use of an ambulatory monitoring system with standard care in hospitalised patients. This feasibility trial will be conducted not only to assess the impact of AMS on early deterioration detection and other clinical outcomes but also to explore recruitment rate, calculate required sample size, number of sites and recruitment period for a full definitive RCT.
Participants will be recruited in one or more surgical wards inside Oxford University Hospitals NHS Foundation Trust (to be decided during feasibility trial, dependant on recruitment rate). Patients will be screened, recruited and participate in this study throughout their hospital stay, no follow-up visits will be required.
The intervention consists in the use of AMS that also includes an alerting system. Participants will wear one pulse oximeter (WristOx2 3150 OEM BLE, shorted to "Nonin", hereafter) measuring pulse rate (PR) and oxygen saturation (SpO2), one chest patch (VitalPatch) that will continuously measure their heart rate (HR), respiratory rate (RR), temperature,; and one A\&D UA-1200 BLE Blood Pressure device, intermittently measuring systolic and diastolic blood pressure, and pulse rate. Clinical staff will be able to access and interact with real-time vital signs through a dashboard style display and will be alerted via a hand-held device, and/or dashboard, according to the patient's EWS score.
The control group will also be fitted with these devices. However, clinical staff will not be able to access the dashboard display or receive alerts.
The trial will include a calibration period inside a surgical unit were the investigators will refine out alerting system. During this period the investigaotors will optimise our alerts through continuous analysis and feedback from the relevant clinical teams. Randomisation will still be conducted during this period.
This feasibility trial will be conducted in surgical units at the John Radcliffe Hospital, Oxford University Hospitals (OUH) NHS Foundation Trust. This will:
- Assess the feasibility of a definitive RCT
- Support sample size calculation for full study
- Assess recruitment rate and the need for inclusion of more wards inside OUH.Staff focus groups or interviews will be held to gather feedback on the system which may inform further refinements, including usability, perceived effect on workload and appropriateness of alerts.
- Multi-professionals staff interviews with be held to assess staff perception of the acceptability of the system in clinical practice. Patients interviews will be held with patient who have worn the monitoring, to gain their perceptions of the system, including wearability, sense of safety and potential improvements.
- Conditions
- Surgery, Deterioration, Clinical
- Being tested
- Ambulatory monitoring system, Active alerting system
- Keywords
- wearables, clinical monitoring, vital signs
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory monitoring systemDevice
Patients will use AMS.
Active alerting systemDevice
Clinical staff alerted if AMS detects deterioration
| Study group | Role | What they receive |
|---|---|---|
| AMS group | Experimental | Patients randomised to the intervention group will receive the AMS; this will be connected to the dashboard and the alerting system. Clinical staff will have access to the dashboard and alerted accordingly for the assigned patients. Receives: Device: Ambulatory monitoring system; Device: Active alerting system |
| Standard Care group | Active comparator | Patients in the control group will also receive the AMS however this will not be connected to the ward dashboard and clinical staff will not be able to access these patient's continuous vital signs:
* Patient will not appear on the ward dashboard
* No alerting system will be given to staff Receives: Device: Ambulatory monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from first period of unexpected physiological instability to set of observations
To assess the impact of AMS integration (with active clinical alerts) versus standard care in deterioration detection
Measured: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
Secondary outcomes (6)
Frequency of periods of physiological instability.
To assess the impact of AMS integration (with active clinical alerts) versus standard care on instability episodes.
Measured: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
Frequency of unscheduled interventions
Frequency of unscheduled interventions. The investigators will collect time and frequency To assess the impact of AMS integration (with active clinical alerts) versus standard care on unscheduled interventions.
to/of unscheduled interventions (as defined in the above intervention examples) in both groups. This will be collected through completion of the relevant CRF/spreadsheet, collecting the following information:
- Unscheduled interventions examples (not limited to these):
- Antibiotics
- Acute changes to therapy/medication (e.g. drugs to treat cardiac arrhythmia)
- Supplementary oxygen
- Fluids
- Radiological intervention (x-ray, CT, etc.)
- Chest physiotherapy
Measured: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
ICU admission rate
To assess the impact of AMS integration (with active clinical alerts) versus standard care other deterioration related outcomes.
Measured: Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.
Adverse event/complication rate
To assess the impact of AMS integration (with active clinical alerts) versus standard care other deterioration related outcomes.
The investigators will collect all complication and adverse event in both groups. This will be categorised according to the Clavien-Dindo classification.
Measured: Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.
Cardiac arrest team call frequency
To assess the impact of AMS integration (with active clinical alerts) versus standard care other deterioration related outcomes.
Other deterioration detection outcomes include cardiac arrest team activation where the investigators will collect cardiac arrest team calls and compare in both groups.
Measured: Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.
Time difference between deterioration detection by nurse and AMS (control group only).
To assess the potential impact of AMS integration in deterioration detection of the control group
Time difference between deterioration detection by nurse and AMS. As participants in the control group will also be wearing these devices the investigators aim to assess the time difference (in minutes) between the first unexpected deterioration occurred (as defined above) and clinical staff detected it. The investigators will also explore time difference to intervention and related clinical outcomes.
Measured: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start28 Jul 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118477
- Sponsor's protocol ID
- PID15556
- Acronym
- vHDU phase 5
- Status last verified
- Feb 2026
- First submitted
- 12 Oct 2021
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests will be considered on an individual basis.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Virtual High Dependency Unit (vHDU) Project Phase 5: Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes. A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05118477
- Acronym / sponsor ID
- vHDU phase 5 / PID15556
- Conditions
- Surgery, Deterioration, Clinical
- Keywords
- wearables, clinical monitoring, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sometimes in hospital, it is not noticed that patients are becoming unwell quickly enough. This may mean that they are less likely to survive than if the worsening of their illness had been picked up sooner. One reason for this may be that hospital staff are unable to check patients' vital signs (such as breathing rate, heart rate and level of oxygen in their blood) frequently enough to help them decide if a patient is becoming more unwell. Currently, for nurses to watch these vital signs closely, patients are either attached to a static machine by the patient's bedside using wires, or staff visit the patient every few hours to measure these vital signs using a portable wired machine. It is now possible to closely monitor patients using small devices which attach to the wrist, finger or chest. These devices allow nursing staff to continually watch vital signs data from these patients when they are away from their bedside. These machines are also wireless and portable, so they do not stop patients moving around, which is important for recovery, and are comfortable to wear. In past years, the investigators have tested these devices and developed a system to allow the clinical staff to see the continuous vital signs. In this final stage of the project, the investigators will test this system (with the selected devices) on patients in hospital. The investigators will start by doing a small trial on one surgical ward, and asking for staff and patient feedback of how the system worked, how useful it was, and how easy to use. If the feedback from this first small trial is positive, the investigators will conduct a future trial in several hospitals, to test how useful the system is in improving patient recovery.
Detailed description
The primary objective of this study is to assess the impact of ambulatory monitoring systems (AMS) integration (with active clinical alerts) versus standard care in deterioration detection.
Secondary objectives include other deterioration detection and clinical outcomes, trial progression outcomes, staff impact and alerting system performance, overall system reliability and patient experience.
This study is a superiority feasibility randomised controlled trial with two-arm parallel groups and 1:1 allocation ratio to compare the use of an ambulatory monitoring system with standard care in hospitalised patients. This feasibility trial will be conducted not only to assess the impact of AMS on early deterioration detection and other clinical outcomes but also to explore recruitment rate, calculate required sample size, number of sites and recruitment period for a full definitive RCT.
Participants will be recruited in one or more surgical wards inside Oxford University Hospitals NHS Foundation Trust (to be decided during feasibility trial, dependant on recruitment rate). Patients will be screened, recruited and participate in this study throughout their hospital stay, no follow-up visits will be required.
The intervention consists in the use of AMS that also includes an alerting system. Participants will wear one pulse oximeter (WristOx2 3150 OEM BLE, shorted to "Nonin", hereafter) measuring pulse rate (PR) and oxygen saturation (SpO2), one chest patch (VitalPatch) that will continuously measure their heart rate (HR), respiratory rate (RR), temperature,; and one A\&D UA-1200 BLE Blood Pressure device, intermittently measuring systolic and diastolic blood pressure, and pulse rate. Clinical staff will be able to access and interact with real-time vital signs through a dashboard style display and will be alerted via a hand-held device, and/or dashboard, according to the patient's EWS score.
The control group will also be fitted with these devices. However, clinical staff will not be able to access the dashboard display or receive alerts.
The trial will include a calibration period inside a surgical unit were the investigators will refine out alerting system. During this period the investigaotors will optimise our alerts through continuous analysis and feedback from the relevant clinical teams. Randomisation will still be conducted during this period.
This feasibility trial will be conducted in surgical units at the John Radcliffe Hospital, Oxford University Hospitals (OUH) NHS Foundation Trust. This will:
- Assess the feasibility of a definitive RCT
- Support sample size calculation for full study
- Assess recruitment rate and the need for inclusion of more wards inside OUH.Staff focus groups or interviews will be held to gather feedback on the system which may inform further refinements, including usability, perceived effect on workload and appropriateness of alerts.
- Multi-professionals staff interviews with be held to assess staff perception of the acceptability of the system in clinical practice. Patients interviews will be held with patient who have worn the monitoring, to gain their perceptions of the system, including wearability, sense of safety and potential improvements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMS group | Experimental | Device: Ambulatory monitoring system, Device: Active alerting systemPatients randomised to the intervention group will receive the AMS; this will be connected to the dashboard and the alerting system. Clinical staff will have access to the dashboard and alerted accordingly for the assigned patients. |
| Standard Care group | Active comparator | Device: Ambulatory monitoring systemPatients in the control group will also receive the AMS however this will not be connected to the ward dashboard and clinical staff will not be able to access these patient's continuous vital signs: * Patient will not appear on the ward dashboard * No alerting system will be given to staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient stable for at least 6 hours with at least one of the following:
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Any patient admitted to the participating surgical unit (including post-ICU patients) who are not currently monitored with standard continuous monitoring
Key exclusion criteria (3 listed)
- The participant may not enter the trial if ANY of the following apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory monitoring systemPatients will use AMS. | Device | AMS group, Standard Care group |
| Active alerting systemClinical staff alerted if AMS detects deterioration | Device | AMS group |
Primary outcome
Time from first period of unexpected physiological instability to set of observations
Time frame: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
To assess the impact of AMS integration (with active clinical alerts) versus standard care in deterioration detection
6 secondary outcomes
Frequency of periods of physiological instability.
Time frame: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
Frequency of unscheduled interventions
Time frame: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
ICU admission rate
Time frame: Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.
Adverse event/complication rate
Time frame: Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.
Cardiac arrest team call frequency
Time frame: Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.
Time difference between deterioration detection by nurse and AMS (control group only).
Time frame: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. Requests will be considered on an individual basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Watkinson, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory monitoring system and Active alerting system in people with Surgery and Deterioration, Clinical, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from first period of unexpected physiological instability to set of observations (time frame: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.