Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery (SMART ANGEL 2)

Centre Hospitalier Universitaire de Nīmes

Status: Unknown

Conditions: Ambulatory Surgery

Treatments: Other: Smart Angel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04068584

CIVI/2018/PC-01

Details and patient eligibility

About

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).

Enrollment: 1,260 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,260 participants in 3 patient groups

Complete Smart Angel

Experimental group

Description:

Smat Angel application with artificial intelligence

Treatment:

Other: Smart Angel

Basic Smart Angel

Experimental group

Description:

Smat Angel application without artificial intelligence

Treatment:

Other: Smart Angel

Control

No Intervention group