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| Name | Class |
|---|---|
| Evolucare Technologies | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete Smart Angel | Experimental | Smat Angel application with artificial intelligence |
|
| Basic Smart Angel | Experimental | Smat Angel application without artificial intelligence |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Angel | Other | Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms |
|
| 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 |
| 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 |
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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:
The patient has sufficient intellectual and cognitive capacity to use the devices
The patient must pass the test performed during the anesthesia consultation, namely:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christhophe Boisson | CHU Nimes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bonnefon | Alès | 30100 | France | |||
| Centre hospitalier universitaire Amiens-Picardie |
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| 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 |
| Amiens |
| 80054 |
| France |
| Hôpital Privé les Bonnettes | Arras | 62000 | France |
| Centre Hospitalier Henri Duffaut | Avignon | 84000 | France |
| CHU Lille | Lille | 59000 | France |
| Hopital Nord | Marseille | 13915 | France |
| Hôpital Lapeyronie | Montpellier | 34090 | France |
| CHU de Nimes | Nîmes | 30029 | France |
| Polyclinique Grand Sud | Nîmes | 30900 | France |
| Institut Mutualiste Montsouris | Paris | 75674 | France |
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
| Clinique St Jean | Saint-Jean-de-Védas | 34430 | France |