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

Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery: Randomized Controlled Open-label Trial

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).

Study Overview

• Status: Completed
• Conditions: Ambulatory Surgery
• Intervention / Treatment: Other: Smart Angel

• Study Type: Interventional
• Enrollment (Actual): 1260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alès, France, 30100
    • Clinique Bonnefon
  • Amiens, France, 80054
    • Centre Hospitalier Universitaire Amiens-Picardie
  • Arras, France, 62000
    • Hôpital Privé les Bonnettes
  • Avignon, France, 84000
    • Centre Hospitalier Henri Duffaut
  • Lille, France, 59000
    • CHU Lille
  • Marseille, France, 13915
    • Hôpital Nord
  • Montpellier, France, 34090
    • Hopital Lapeyronie
  • Nîmes, France, 30029
    • CHU de Nîmes
  • Nîmes, France, 30900
    • Polyclinique Grand Sud
  • Paris, France, 75674
    • Institut Mutualiste Montsouris
  • Saint-Etienne, France, 42055
    • CHU de Saint-Etienne
  • Saint-Jean-de-Védas, France, 34430
    • Clinique St Jean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Evolucare Technologies
• Investigators: Study Director: Christhophe Boisson, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): November 18, 2024

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CIVI/2018/PC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No