Clinical deterioration of vital sign parameters such as blood pressure, oxygen levels. heart rate or respiratory rate. Signs and Symptoms
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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