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 |
|---|---|---|
| Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm. | Day 2 post operative | Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional, The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system. The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREric NOLL, MD
Hôpitaux Universitaires de Strasbourg
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64 year |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed