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

NCT04068584 | Completed

• 1 other identifier: CIVI/2018/PC-01
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 12

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).

Conditions

Ambulatory Surgery

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (14)

• Rate of complications between groups

  Day 1

• Rate of complications between groups

  Day 2

• Rate of complications between groups

  Day 3

• Rate of complications between groups

  Day 4

• Rate of complications between groups

  Day 5

Study Arms (3)

Complete Smart Angel

EXPERIMENTAL

Smat Angel application with artificial intelligence

Other: Smart Angel

Basic Smart Angel

EXPERIMENTAL

Smat Angel application without artificial intelligence

Other: Smart Angel

Control

NO INTERVENTION

Interventions

Smart Angel OTHER

Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms

Basic Smart Angel; Complete Smart Angel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Evolucare Technologies: collaborator

Study Sites (12)

Clinique Bonnefon

Alès, 30100, France

Location

Centre hospitalier universitaire Amiens-Picardie

Amiens, 80054, France

Location

Hôpital Privé les Bonnettes

Arras, 62000, France

Location

Centre Hospitalier Henri Duffaut

Avignon, 84000, France

Location

CHU Lille

Lille, 59000, France

Location

Hopital Nord

Marseille, 13915, France

Location

Hôpital Lapeyronie

Montpellier, 34090, France

Location

CHU de Nimes

Nîmes, 30029, France

Location

Polyclinique Grand Sud

Nîmes, 30900, France

Location

Institut Mutualiste Montsouris

Paris, 75674, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Clinique St Jean

Saint-Jean-de-Védas, 34430, France

Location

Study Officials

• Christhophe Boisson

  CHU Nimes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: February 3, 2020
• Primary Completion: October 21, 2024
• Study Completion: November 18, 2024
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

FR (12)