Impact of a wearable monitoring system on detecting patient deterioration
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
This study is testing whether a new wearable monitoring system can help doctors spot problems earlier in hospitalized patients compared to regular monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT05118477 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an ambulatory monitoring system (AMS) that continuously tracks patients' vital signs compared to standard care in detecting clinical deterioration in hospitalized patients. The trial involves a randomized controlled design with two groups: one using the AMS with active alerts and the other receiving standard monitoring. It aims to assess not only the detection of deterioration but also the overall clinical outcomes, staff impact, and patient experience. Participants will be recruited from surgical wards at Oxford University Hospitals NHS Foundation Trust and will wear monitoring devices throughout their hospital stay.
Who should consider this trial
Good fit: Ideal candidates include hospitalized surgical patients who are stable for at least 6 hours and not currently under continuous monitoring.
Not a fit: Patients with intra-cardiac devices or those monitored for less than 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of patient deterioration, potentially improving survival rates and clinical outcomes.
How similar studies have performed: Other studies have shown promise in using wearable technology for patient monitoring, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * The participant may not enter the trial if ANY of the following apply: * Intra-cardiac device * Monitored for less than 24 hours
Where this trial is running
Oxford, Oxfordshire
- Oxford University Hospitals Trust — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Peter Watkinson, MD — University of Oxford
- Study coordinator: Sarah Vollam, PhD
- Email: sarah.vollam@ndcn.ox.ac.uk
- Phone: +441865 231440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.