Ambulatory Surgery
Conditions
Brief summary
The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).
Interventions
OTHERSmart Angel
Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms
Sponsors
Centre Hospitalier Universitaire de Nīmes
Evolucare Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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 undergoing ambulatory surgery for: * in orthopedics: shoulder (arthroscopy, abutment, prosthesis), hip (prosthesis, arthrolysis), knee (osteotomy, ligamentoplasty), ankle (prosthesis, ligamentoplasty) foot (hallux valgus); removal of major or multi-site equipment; * digestive (cholecystectomy, hernia repair, partial gastrectomy, colectomy, cleaning); * in gynecology (hysterectomy, oophorectomy, mastectomy, quadrantectomy, dissection, cystoplasty, sphincter); * in urology (total or partial resection of the prostate); * ENT (thyroidectomy, tonsillectomy); * Neurosurgery (herniated disc); * Vascular (stripping varix, creating fistula). * The patient has sufficient intellectual and cognitive capacity to use the devices * The patient must pass the test performed during the anesthesia consultation, namely: * open and connect the tablet, * activate the measurement of the blood pressure and the measurement of the oxygen saturation, * be connected to a 4G network
Exclusion criteria
* The subject 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 is undergoing emergency or minor surgery * Patient has a psychological class ASA 5 * Patient is non-eligible for ambulatory surgery for medical reasons (decompensated medical pathology) or social reasons according to the criteria defined by the société française anesthésie réanimation. Person lives alone or has a geographical distance from a hospital center\> 30 km (or\> 45 min by car). * Patient who doesn't classify for ambulatory surgery at time of discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-scheduled hospitalization rates between groups | Day 5 | % |
| Number of non-scheduled consultations between groups | Day 5 | % |
| Rates of calls with nurses between groups | Day 5 | % |
| Rates of calls with doctors between groups | Day 5 | % |
| Rates of unplanned prescriptions between groups | Day 5 | % |
| Rates of unplanned exams between groups | Day 5 | % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complications between groups | Day 1 | % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising |
| Rate of readmission between groups | Month 1 | Yes/No |
| Date of return to work or other activity | 1 Month | Dd/mm/yyyy |
| Patient satisfaction | Day 6 | Visual Analog Scale 0-10 |
| Patient quality of life | 1 month | EQ-5D-5L questionnaire taken over the phone |
| Difficulties in using the device | Day 5 | In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff |
| Requirement of external help in using the device | Day 5 | Description of person sought for advice |
| Times spent on device | Day 5 | Hours; automatically calculated by device for time used for manipulation and time for navigation |
| Technical errors arising | Day 5 | Automatically calculated by device |
Countries
France
Contacts
STUDY_DIRECTORChristhophe Boisson
CHU Nimes
Outcome results
None listed