vHDU Phase 5: Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes

NCT05118477 | Completed

• 1 other identifier: PID15556
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgery; Deterioration, Clinical

Keywords

wearables; clinical monitoring; vital signs

Outcome Measures

Primary Outcomes (1)

• 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

  Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.

Secondary Outcomes (6)

• Frequency of periods of physiological instability.

  Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.

• Frequency of unscheduled interventions

  Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.

• ICU admission rate

  Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.

• Adverse event/complication rate

  Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.

• Cardiac arrest team call frequency

  Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.

Study Arms (2)

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.

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

Device: Ambulatory monitoring system

Interventions

Ambulatory monitoring system DEVICE

Patients will use AMS.

AMS group; Standard Care group

Active alerting system DEVICE

Clinical staff alerted if AMS detects deterioration

AMS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The participant may not enter the trial if ANY of the following apply:
• Intra-cardiac device
• Monitored for less than 24 hours

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Oxford University Hospitals Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Watkinson, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 12, 2021
• Study Start: July 28, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)