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Can the use of wrist or chest-worn wearable devices that measure heart rate, oxygen levels and breathing rate improve the detection of in-hospital patient deterioration-the Virtual High Dependency Unit Study?

Virtual HDU Phase 4: Ambulatory monitoring system user interface integration and development.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN51530527
Enrollment
78
Registered
2019-07-26
Start date
2019-08-01
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical deterioration of vital sign parameters such as blood pressure, oxygen levels. heart rate or respiratory rate. Signs and Symptoms

Interventions

The first stage of this study aims to understand the clinical user requirements for an AMS-SEND interface. This interface will allow clinical staff to capture and review clinical data from the AMS. A

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Stage A: Staff Focus Group/Interviews 1. Any clinical staff member who uses SEND or measures patient vital signs Study B: Locational testing of AMS 1. Willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Admitted to a surgical emergency unit (including post-ICU patients) and not currently monitored with continuous monitoring Study C: Usability Testing 1. Any clinical staff member who uses SEND and measures patient vital signs 2. Any staff member who may be an end user of a AMS-SEND system

Exclusion criteria

Exclusion criteria: Stage A: Staff Focus Group/Interviews 1. Any staff member who cannot give informed consent Stage B: Locational testing of AMS 1. Allergies to nickel. 2. Intra-cardiac device 3. Already on continuous monitoring 4. Diagnosed dementia Stage C: Usability testing 1. Any staff member who cannot give informed consent

Design outcomes

Primary

MeasureTime frame
1. The functionality of the interface is determined using the following measures at the end of the study. 1.1. Completed AMS and SEND integration with user interface. 1.2. Real-time AMS data. 1.3. Completed user interface.

Secondary

MeasureTime frame
1. End-user requirements for the AMS-SEND linked system is determined using collated end-user requirements at the end of stage A. 2. The reliability of data recording in a clinical setting is determined using the proportion of time windows each vital sign (heart rate, SPO2 and breathing rate) is recorded versus time the device is worn at the end of stage B. 3. The reliability and wearability in a clinical setting is determined using the following measures throughout the study: 3.1. Frequency and duration of data drop-out for each vital sign parameter. 3.2. Waveform quality of each vital sign parameter. 3.3. Wearability questionnaire. 4. User interface design optimisation is determined using the following measures throughout the study: 4.1. Satisfaction - System Usability Scale. 4.2. Effectiveness – >80% correctness of specific tasks. 4.3. Efficiency – time to complete task better than currently. 4.4. Workload – NASA TLX ensuring workload to interpret data is not too high.

Countries

United Kingdom

Contacts

Public ContactCarlos Areia
carlos.morgadoareia@ndcn.ox.ac.uk018 6523 1440

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026