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

NCT03464721 | Completed

• 2 other identifiers: IDIL/2017/PC-012017-A02790-53
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Surgery

Outcome Measures

Primary Outcomes (12)

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

  Data collected and transmitted

  Day 0

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

  Data collected and transmitted

  Day 1

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

  Data collected and transmitted

  Day 2

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

  Data collected and transmitted

  Day 3

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

  Data collected and transmitted

  Day 4

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

  Data collected and transmitted

  Day 5

• Concordance between data collected on tablet versus paper copies

  Percentage correct measures

  Day 0

• Concordance between data collected on tablet versus paper copies

  Percentage correct measures

  Day 1

• Concordance between data collected on tablet versus paper copies

  Percentage correct measures

  Day 2

• Concordance between data collected on tablet versus paper copies

  Percentage correct measures

  Day 3

• Concordance between data collected on tablet versus paper copies

  Percentage correct measures

  Day 4

• Concordance between data collected on tablet versus paper copies

  Percentage correct measures

  Day 5

Secondary Outcomes (4)

• 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

• Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate

  End of inclusion period: Month 18

Study Arms (1)

Surgery Outpatients

EXPERIMENTAL

Device: issued with SMART ANGEL device

Interventions

issued with SMART ANGEL device DEVICE

patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation

Surgery Outpatients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

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 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 33032541 RESULT

Study Officials

• Philippe Cuvillon

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: May 14, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 22, 2025

Record last verified: 2019-01

Locations

FR (1)