Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery

Centre Hospitalier Universitaire de Nīmes1 site in 1 country30 target enrollmentMay 14, 2018

ConditionsSurgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgery
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 30
Locations: 1
Primary Endpoint: Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 14, 2018

End Date

September 30, 2018

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

Time Frame: Day 5

Data collected and transmitted

Concordance between data collected on tablet versus paper copies

Time Frame: Day 5

Percentage correct measures

Secondary Outcomes

Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate(End of inclusion period: Month 18)
Ease of use of medical device according to patient(Day 5)
Qualitative decision-making ability from pooled results of all data from all patients(End of inclusion: Month 18)
Readmission rate(Month 1)