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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2022

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Complete Smart Angel
    • Smat Angel application with artificial intelligence
  • Experimental: Basic Smart Angel
    • Smat Angel application without artificial intelligence
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

  • Non-scheduled hospitalization rates between groups
    • Time Frame: Day 5
  • Number of non-scheduled consultations between groups
    • Time Frame: Day 5
  • Rates of calls with nurses between groups
    • Time Frame: Day 5
  • Rates of calls with doctors between groups
    • Time Frame: Day 5
  • Rates of unplanned prescriptions between groups
    • Time Frame: Day 5
  • Rates of unplanned exams between groups
    • Time Frame: Day 5

Secondary Measures

  • Rate of complications between groups
    • Time Frame: Day 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 complications between groups
    • Time Frame: Day 2
    • % 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 complications between groups
    • Time Frame: Day 3
    • % 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 complications between groups
    • Time Frame: Day 4
    • % 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 complications between groups
    • Time Frame: Day 5
    • % 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 complications between groups
    • Time Frame: 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
    • Time Frame: Month 1
    • Yes/No
  • Date of return to work or other activity
    • Time Frame: 1 Month
    • Dd/mm/yyyy
  • Patient satisfaction
    • Time Frame: Day 6
    • Visual Analog Scale 0-10
  • Patient quality of life
    • Time Frame: 1 month
    • EQ-5D-5L questionnaire taken over the phone
  • Difficulties in using the device
    • Time Frame: Day 5
    • In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff
  • Requirement of external help in using the device
    • Time Frame: Day 5
    • Description of person sought for advice
  • Times spent on device
    • Time Frame: Day 5
    • Hours; automatically calculated by device for time used for manipulation and time for navigation
  • Technical errors arising
    • Time Frame: Day 5
    • Automatically calculated by device

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Collaborator
    • Evolucare Technologies
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christhophe Boisson, Study Director, CHU Nimes
  • Overall Contact(s)
    • Christophe Boisson, +33 0(4) 66 68 30 50, christophe.boisson@chu-nimes.fr

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