Status:
UNKNOWN
Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
Evolucare Technologies
Conditions:
Ambulatory Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ™ devi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
1260 Patients enrolled
Trial Details
Trial ID
NCT04068584
Start Date
February 3 2020
End Date
August 1 2022
Last Update
August 5 2021
Active Locations (24)
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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