Surgery
Conditions
Brief summary
This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient
Interventions
DEVICEissued with SMART ANGEL device
patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is at least 18 years old and less than 80 years old * The patient is undergoing orthopedic (shoulder, foot, knee), digestive (gallbladder) or gynecological (uterus-ovary) adjustment outpatient surgery * The patient has sufficient cognitive and intellectual ability to use the system * The patient must undergo a training test during consultation to use the tablet and perform the measurements * The patient must have access to 4G at home.
Exclusion criteria
* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patient is pregnant * The patient needs emergency surgery * The patient has a level 4 or 5 ASA psychological class * Patient cannot have outpatient surgery for medical reasons (decompensated medical pathology), or social reasons according the the SFAR (société française anesthésie réanimation) criteria. Patient alone at home and geographically far from a hospital \>30km (or \>45 minutes by car).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Day 0 | Data collected and transmitted |
| Concordance between data collected on tablet versus paper copies | Day 0 | Percentage correct measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use of medical device according to patient | Day 5 | System Usability Scale (SUS) : score 0-100 |
| Qualitative decision-making ability from pooled results of all data from all patients | End of inclusion: Month 18 | Group of 2 experts decide whether patients should have been hospitalized, called, or left alone based on retrospective analysis of all data |
| Readmission rate | Month 1 | Percentage of patients readmitted to hospital |
| Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate | End of inclusion period: Month 18 | Group of 2 experts decide whether patients should have been readmitted based on retrospective analysis of all data |
Countries
France
Outcome results
None listed