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Completed

NCT Number: NCT04068584

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

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).

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Key information

Conditions

Ambulatory Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Bonnefon, Alès, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart Angel

Other

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

Primary outcomes

  1. Non-scheduled hospitalization rates between groups

    Time frame: Day 5

    %

  2. Number of non-scheduled consultations between groups

    Time frame: Day 5

    %

  3. Rates of calls with nurses between groups

    Time frame: Day 5

    %

  4. Rates of calls with doctors between groups

    Time frame: Day 5

    %

  5. Rates of unplanned prescriptions between groups

    Time frame: Day 5

    %

  6. Rates of unplanned exams between groups

    Time frame: Day 5

    %

Secondary outcomes

  1. Rate of complications between groups

    Time frame: Day 1

    % 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

  2. Rate of complications between groups

    Time frame: Day 2

    % 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

  3. Rate of complications between groups

    Time frame: Day 3

    % 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

  4. Rate of complications between groups

    Time frame: Day 4

    % 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

  5. Rate of complications between groups

    Time frame: Day 5

    % 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

  6. Rate of complications between groups

    Time frame: Month 1

    % 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

  7. Rate of readmission between groups

    Time frame: Month 1

    Yes/No

  8. Date of return to work or other activity

    Time frame: 1 Month

    Dd/mm/yyyy

  9. Patient satisfaction

    Time frame: Day 6

    Visual Analog Scale 0-10

  10. Patient quality of life

    Time frame: 1 month

    EQ-5D-5L questionnaire taken over the phone

  11. Difficulties in using the device

    Time frame: Day 5

    In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff

  12. Requirement of external help in using the device

    Time frame: Day 5

    Description of person sought for advice

  13. Times spent on device

    Time frame: Day 5

    Hours; automatically calculated by device for time used for manipulation and time for navigation

  14. Technical errors arising

    Time frame: Day 5

    Automatically calculated by device

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Evolucare Technologies

Registry information

Official study 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

Acronym: SMART ANGEL 2

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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