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

Ambulatory Surgery Clinical Trial

— SMART ANGEL 2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068584
• Other study ID #: CIVI/2018/PC-01
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: August 2022

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Christophe Boisson
• Phone: +33 0(4) 66 68 30 50
• Email: christophe.boisson[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Surgery

Intervention

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

Locations

Country	Name	City	State
France	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	Lyon Sud	Lyon
France	Hopital Nord	Marseille
France	Hôpital Lapeyronie	Montpellier
France	Hopital Saint Eloi	Montpellier
France	ICM	Montpellier
France	Clinique des Franciscaines	Nimes
France	CHU de Nimes	Nîmes
France	Clinique Kenval	Nîmes
France	Polyclinique Grand Sud	Nîmes
France	Clinique Jouvenet	Paris
France	Hôpital Universitaire Pitié Salpêtrière	Paris
France	Institut Mutualiste Montsouris	Paris
France	CHU de Rennes	Rennes
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	EVOLUCARE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-scheduled hospitalization rates between groups		Day 5
Primary	Number of non-scheduled consultations between groups		Day 5
Primary	Rates of calls with nurses between groups		Day 5
Primary	Rates of calls with doctors between groups		Day 5
Primary	Rates of unplanned prescriptions between groups		Day 5
Primary	Rates of unplanned exams between groups		Day 5
Secondary	Rate of complications between groups	% 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	Day 1
Secondary	Rate of complications between groups	% 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	Day 2
Secondary	Rate of complications between groups	% 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	Day 3
Secondary	Rate of complications between groups	% 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	Day 4
Secondary	Rate of complications between groups	% 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	Day 5
Secondary	Rate of complications between groups	% 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	Month 1
Secondary	Rate of readmission between groups	Yes/No	Month 1
Secondary	Date of return to work or other activity	Dd/mm/yyyy	1 Month
Secondary	Patient satisfaction	Visual Analog Scale 0-10	Day 6
Secondary	Patient quality of life	EQ-5D-5L questionnaire taken over the phone	1 month
Secondary	Difficulties in using the device	In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff	Day 5
Secondary	Requirement of external help in using the device	Description of person sought for advice	Day 5
Secondary	Times spent on device	Hours; automatically calculated by device for time used for manipulation and time for navigation	Day 5
Secondary	Technical errors arising	Automatically calculated by device	Day 5