NCT04068584

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

August 22, 2019

Last Update Submit

August 4, 2021

Conditions

Ambulatory Surgery

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (14)

  • Rate of complications between groups

    Day 1

  • Rate of complications between groups

    Day 2

  • Rate of complications between groups

    Day 3

  • Rate of complications between groups

    Day 4

  • Rate of complications between groups

    Day 5

  • +9 more secondary outcomes

Study Arms (3)

Complete Smart Angel

EXPERIMENTAL

Smat Angel application with artificial intelligence

Other: Smart Angel

Basic Smart Angel

EXPERIMENTAL

Smat Angel application without artificial intelligence

Other: Smart Angel

Control

NO INTERVENTION

Interventions

Smart AngelOTHER

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

Basic Smart AngelComplete Smart Angel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Polyclinique du Parc Rambot

Aix-en-Provence, 13100, France

NOT YET RECRUITING

Clinique Bonnefon

Alès, 30100, France

NOT YET RECRUITING

Centre hospitalier universitaire Amiens-Picardie

Amiens, 80054, France

NOT YET RECRUITING

Centre hospitalier D'Arles

Arles, 13637, France

NOT YET RECRUITING

Centre Hospitalier Henri Duffaut

Avignon, 84000, France

NOT YET RECRUITING

CHU Bordeaux II

Bordeaux, 33000, France

NOT YET RECRUITING

CH antoine gayraud

Carcassonne, France

NOT YET RECRUITING

Hôpital Henri-Mondor

Créteil, 94010, France

NOT YET RECRUITING

CHU Lille

Lille, 59000, France

NOT YET RECRUITING

Clinique Via Domitia

Lunel, 34400, France

NOT YET RECRUITING

Lyon Sud

Lyon, France

NOT YET RECRUITING

Hopital Nord

Marseille, 13915, France

NOT YET RECRUITING

ICM

Montpellier, 34000, France

NOT YET RECRUITING

Hopital Saint Eloi

Montpellier, 34090, France

NOT YET RECRUITING

Hôpital Lapeyronie

Montpellier, 34090, France

NOT YET RECRUITING

CHU de Nimes

Nîmes, 30029, France

RECRUITING

Clinique des Franciscaines

Nîmes, 30032, France

NOT YET RECRUITING

Clinique Kenval

Nîmes, 30900, France

NOT YET RECRUITING

Polyclinique Grand Sud

Nîmes, 30900, France

NOT YET RECRUITING

Clinique Jouvenet

Paris, 75016, France

NOT YET RECRUITING

Hôpital Universitaire Pitié Salpêtrière

Paris, 75651, France

NOT YET RECRUITING

Institut Mutualiste Montsouris

Paris, 75674, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35033, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

NOT YET RECRUITING

Study Officials

  • Christhophe Boisson

    CHU Nimes

    STUDY DIRECTOR

Central Study Contacts

Christophe Boisson

CONTACT

+33 0(4) 66 68 30 50christophe.boisson@chu-nimes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

February 3, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations

FR(24)