Post-operative Situation
Conditions
Keywords
prototype software, patient interface, experimental medical device
Brief summary
The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems. The study hypothesis is that the clinical use of the experimental device is feasible.
Interventions
DEVICEsoftware
The experimental medical device is a prototype software. It is a patient interface. The device comes in the form of a smartphone with a touch screen
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female 18 years or older (no upper age limit) * Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg * Patient understanding and reading French * Subject neurosensorially able of interacting with a tactile electronical interface * Subject able to understand research objectives, risks and provide dated and signed informed consent * Subject covered by a health insurance scheme
Exclusion criteria
* Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface * Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.) * Pregnant or lactating woman (on declaration) * Patient under safeguard of justice, under guardianship, under curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the feasibility of the INSAMED computer tool | Day 2 post operative | agreement between INSAMED computer tool and the recommendations established by caregivers. The data from INSAMED computer tool will be collected by extracting the history of the digital interface (commercial smartphone) hosting the expert system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the time delay, in usual care setting, of rescue drug administrations after surgery, to confirm the interest of developing expert systems to improve the existing one. | 60 minutes after software activation | Delay, in minutes, between soliciting a ward nurse as usual practice (e.g., doorbell) and the administration of the therapeutic response. This time will be collected by the Research IDE during patient interview. 60 minutes after software activation. The patient will simultaneously request the standard care IDE (doorbell) and the INSAMED tool. |
| Assess patient satisfaction with usual care | 60 minutes after software activation. | Patient satisfaction with the routine care therapeutic response measured by an analog visual scale between 0 and 100, measured 60 minutes after software activation. |
| Assess patient satisfaction with the ease of use of the experimental device | 60 minutes after software activation. | Patient satisfaction with the ease of use of the INSAMED device measured by an analog visual scale between 0 and 100, measured 60 minutes after software activation |
| assess the security of the device | Day 2 post operative | Safety analysis of INSAMED software through evaluation of serious adverse events based on a expert panel reviewing. |
Countries
France
Outcome results
None listed