SMART ANGEL 2: Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Complete Smart Angel Smat Angel application with artificial intelligence |
Other: Smart Angel
Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms
|
| Experimental: Basic Smart Angel Smat Angel application without artificial intelligence |
Other: Smart Angel
Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 complications between groups [Day 2]
% 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 complications between groups [Day 3]
% 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 complications between groups [Day 4]
% 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 complications between groups [Day 5]
% 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 complications between groups [Month 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Polyclinique du Parc Rambot | Aix-en-Provence | France | 13100 | |
| 2 | Clinique Bonnefon | Alès | France | 30100 | |
| 3 | Centre hospitalier universitaire Amiens-Picardie | Amiens | France | 80054 | |
| 4 | Centre hospitalier D'Arles | Arles | France | 13637 | |
| 5 | Centre Hospitalier Henri Duffaut | Avignon | France | 84000 | |
| 6 | CHU Bordeaux II | Bordeaux | France | 33000 | |
| 7 | CH antoine gayraud | Carcassonne | France | ||
| 8 | Hôpital Henri-Mondor | Créteil | France | 94010 | |
| 9 | CHU Lille | Lille | France | 59000 | |
| 10 | Clinique Via Domitia | Lunel | France | 34400 | |
| 11 | Lyon Sud | Lyon | France | ||
| 12 | Hopital Nord | Marseille | France | 13915 | |
| 13 | ICM | Montpellier | France | 34000 | |
| 14 | Hopital Saint Eloi | Montpellier | France | 34090 | |
| 15 | Hôpital Lapeyronie | Montpellier | France | 34090 | |
| 16 | Clinique des Franciscaines | Nimes | France | 30032 | |
| 17 | CHU de Nimes | Nîmes | France | 30029 | |
| 18 | Clinique Kenval | Nîmes | France | 30900 | |
| 19 | Polyclinique Grand Sud | Nîmes | France | 30900 | |
| 20 | Clinique Jouvenet | Paris | France | 75016 | |
| 21 | Hôpital Universitaire Pitié Salpêtrière | Paris | France | 75651 | |
| 22 | Institut Mutualiste Montsouris | Paris | France | 75674 | |
| 23 | CHU de Rennes | Rennes | France | 35033 | |
| 24 | CHU de Saint-Etienne | Saint-Étienne | France | 42055 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
- EVOLUCARE
Investigators
- Study Director: Christhophe Boisson, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIVI/2018/PC-01