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

Not Applicable

• Conditions: Ambulatory Surgery
• Interventions: Other: Smart Angel

• Registration Number: NCT04068584
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Study Start: 2020-02-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete Smart Angel	Smart Angel	Smat Angel application with artificial intelligence
Basic Smart Angel	Smart Angel	Smat Angel application without artificial intelligence

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Requirement of external help in using the device	Day 5	Description of person sought for advice
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
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

Trial Locations

Locations (24)

Polyclinique du Parc Rambot; 🇫🇷 Aix-en-Provence, France

Clinique Bonnefon; 🇫🇷 Alès, France

Centre hospitalier universitaire Amiens-Picardie; 🇫🇷 Amiens, France

Centre hospitalier D'Arles; 🇫🇷 Arles, France

Centre Hospitalier Henri Duffaut; 🇫🇷 Avignon, France

CHU Bordeaux II; 🇫🇷 Bordeaux, France

CH antoine gayraud; 🇫🇷 Carcassonne, France

Hôpital Henri-Mondor; 🇫🇷 Créteil, France

CHU Lille; 🇫🇷 Lille, France

Clinique Via Domitia; 🇫🇷 Lunel, France

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