Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery: Randomized Controlled Open-label Trial

Conditions
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Ambulatory Surgery

Intervention / Treatment
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* Other: Smart Angel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complete Smart Angel<br>Smat Angel application with artificial intelligence | Other: Smart Angel<br>* Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms<br>|
| Experimental: Basic Smart Angel<br>Smat Angel application without artificial intelligence | Other: Smart Angel<br>* Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications between groups | % 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 | Day 1 | 
| Rate of complications between groups | % 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 | Day 2 | 
| Rate of complications between groups | % 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 | Day 3 | 
| Rate of complications between groups | % 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 | Day 4 | 
| Rate of complications between groups | % 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 | Day 5 | 
| Rate of complications between groups | % 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 | Month 1 | 
| Rate of readmission between groups | Yes/No | Month 1 | 
| Date of return to work or other activity | Dd/mm/yyyy | 1 Month | 
| Patient satisfaction | Visual Analog Scale 0-10 | Day 6 | 
| Patient quality of life | EQ-5D-5L questionnaire taken over the phone | 1 month | 
| Difficulties in using the device | In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff | Day 5 | 
| Requirement of external help in using the device | Description of person sought for advice | Day 5 | 
| Times spent on device | Hours; automatically calculated by device for time used for manipulation and time for navigation | Day 5 | 
| Technical errors arising | Automatically calculated by device | Day 5 |