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

Last updated: August 4, 2021
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04068584
CIVI/2018/PC-01
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consentform
  • 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 oxygensaturation,
  • be connected to a 4G network

Exclusion

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 (decompensatedmedical pathology) or social reasons according to the criteria defined by the sociétéfrançaise anesthésie réanimation. Person lives alone or has a geographical distancefrom a hospital center> 30 km (or> 45 min by car).
  • Patient who doesn't classify for ambulatory surgery at time of discharge

Study Design

Total Participants: 1260
Study Start date:
February 03, 2020
Estimated Completion Date:
August 31, 2022

Connect with a study center

  • Polyclinique du Parc Rambot

    Aix-en-Provence, 13100
    France

    Site Not Available

  • Clinique Bonnefon

    Alès, 30100
    France

    Site Not Available

  • Centre hospitalier universitaire Amiens-Picardie

    Amiens, 80054
    France

    Site Not Available

  • Centre hospitalier D'Arles

    Arles, 13637
    France

    Site Not Available

  • Centre Hospitalier Henri Duffaut

    Avignon, 84000
    France

    Site Not Available

  • CHU Bordeaux II

    Bordeaux, 33000
    France

    Site Not Available

  • CH antoine gayraud

    Carcassonne,
    France

    Site Not Available

  • Hôpital Henri-Mondor

    Créteil, 94010
    France

    Site Not Available

  • CHU Lille

    Lille, 59000
    France

    Site Not Available

  • Clinique Via Domitia

    Lunel, 34400
    France

    Site Not Available

  • Lyon Sud

    Lyon,
    France

    Site Not Available

  • Hopital Nord

    Marseille, 13915
    France

    Site Not Available

  • Hopital Saint Eloi

    Montpellier, 34090
    France

    Site Not Available

  • Hôpital Lapeyronie

    Montpellier, 34090
    France

    Site Not Available

  • ICM

    Montpellier, 34000
    France

    Site Not Available

  • Clinique des Franciscaines

    Nimes, 30032
    France

    Site Not Available

  • CHU de Nimes

    Nîmes, 30029
    France

    Active - Recruiting

  • Clinique Kenval

    Nîmes, 30900
    France

    Site Not Available

  • Polyclinique Grand Sud

    Nîmes, 30900
    France

    Site Not Available

  • Clinique Jouvenet

    Paris, 75016
    France

    Site Not Available

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, 75651
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris, 75674
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Étienne, 42055
    France

    Site Not Available

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