Clinical trial NCT04068584: Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ambulatory Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Evolucare Technologies
First posted: 2019-08-28
Enrollment: 1260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Non-scheduled hospitalization rates between groups
timeFrame: Day 5
measure: Number of non-scheduled consultations between groups
timeFrame: Day 5
measure: Rates of calls with nurses between groups
timeFrame: Day 5
measure: Rates of calls with doctors between groups
timeFrame: Day 5
measure: Rates of unplanned prescriptions between groups
timeFrame: Day 5
measure: Rates of unplanned exams between groups
timeFrame: Day 5
Secondary outcomes:
measure: Rate of complications between groups
timeFrame: Day 1
measure: Rate of complications between groups
timeFrame: Day 2
measure: Rate of complications between groups
timeFrame: Day 3
measure: Rate of complications between groups
timeFrame: Day 4
measure: Rate of complications between groups
timeFrame: Day 5
measure: Rate of complications between groups
timeFrame: Month 1
measure: Rate of readmission between groups
timeFrame: Month 1
measure: Date of return to work or other activity
timeFrame: 1 Month
measure: Patient satisfaction
timeFrame: Day 6
measure: Patient quality of life
timeFrame: 1 month
measure: Difficulties in using the device
timeFrame: Day 5
measure: Requirement of external help in using the device
timeFrame: Day 5
measure: Times spent on device
timeFrame: Day 5
measure: Technical errors arising
timeFrame: Day 5
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Polyclinique du Parc Rambot
city: Alès
country: France
facility: Clinique Bonnefon
city: Amiens
country: France
facility: Centre hospitalier universitaire Amiens-Picardie
city: Arles
country: France
facility: Centre hospitalier D'Arles
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
city: Bordeaux
country: France
facility: CHU Bordeaux II
city: Carcassonne
country: France
facility: CH antoine gayraud
city: Créteil
country: France
facility: Hôpital Henri-Mondor
city: Lille
country: France
facility: CHU Lille
city: Lunel
country: France
facility: Clinique Via Domitia
city: Lyon
country: France
facility: Lyon Sud
city: Marseille
country: France
facility: Hopital Nord
city: Montpellier
country: France
facility: ICM
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Nimes
country: France
facility: Clinique des Franciscaines
city: Nîmes
country: France
facility: CHU de Nimes
city: Nîmes
country: France
facility: Clinique Kenval
city: Nîmes
country: France
facility: Polyclinique Grand Sud
city: Paris
country: France
facility: Clinique Jouvenet
city: Paris
country: France
facility: Hôpital Universitaire Pitié Salpêtrière
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU Nimes
name: Christhophe Boisson
role: STUDY_DIRECTOR
References: