Clinical trial NCT03464721: Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery
Official title: Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients screened at CHU Nimes for consultation for preoperative anesthesia for surgery as an outpatient for foot, shoulder, gall bladder (cholecystectomy) or uterus (hysterectomy, ovariectomy).

Brief summary: This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient


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 at least 18 years old and less than 80 years old
* The patient is undergoing orthopedic (shoulder, foot, knee), digestive (gallbladder) or gynecological (uterus-ovary) adjustment outpatient surgery
* The patient has sufficient cognitive and intellectual ability to use the system
* The patient must undergo a training test during consultation to use the tablet and perform the measurements
* The patient must have access to 4G at home.

Exclusion Criteria:

* The subject is participating in an interventional study, or 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 needs emergency surgery
* The patient has a level 4 or 5 ASA psychological class
* Patient cannot have outpatient surgery for medical reasons (decompensated medical pathology), or social reasons according the the SFAR (société française anesthésie réanimation) criteria. Patient alone at home and geographically far from a hospital \>30km (or \>45 minutes by car).

Primary outcomes:
measure: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
timeFrame: Day 0
measure: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
timeFrame: Day 1
measure: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
timeFrame: Day 2
measure: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
timeFrame: Day 3
measure: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
timeFrame: Day 4
measure: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
timeFrame: Day 5
measure: Concordance between data collected on tablet versus paper copies
timeFrame: Day 0
measure: Concordance between data collected on tablet versus paper copies
timeFrame: Day 1
measure: Concordance between data collected on tablet versus paper copies
timeFrame: Day 2
measure: Concordance between data collected on tablet versus paper copies
timeFrame: Day 3
measure: Concordance between data collected on tablet versus paper copies
timeFrame: Day 4
measure: Concordance between data collected on tablet versus paper copies
timeFrame: Day 5
Secondary outcomes:
measure: Ease of use of medical device according to patient
timeFrame: Day 5
measure: Qualitative decision-making ability from pooled results of all data from all patients
timeFrame: End of inclusion: Month 18
measure: Readmission rate
timeFrame: Month 1
measure: Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate
timeFrame: End of inclusion period: Month 18
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Philippe Cuvillon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chevallier T, Buzancais G, Occean BV, Rataboul P, Boisson C, Simon N, Lannelongue A, Chaniaud N, Gricourt Y, Lefrant JY, Cuvillon P. Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel app and an original web platform for patients following outpatient surgery: a prospective observational pilot study. BMC Anesthesiol. 2020 Oct 8;20(1):259. doi: 10.1186/s12871-020-01178-5.