Technical Capabilities of the “SMART ANGEL Intra-hospital” System ‘s Connected Medical Device (CMD)

Overview

Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies. Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure. Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.

Full Title of Study: “Assessment of the Technical Capabilities of the “SMART ANGEL” Intra-hospital System ‘s Connected Medical Device (CMD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

Detailed Description

The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using a Connected Medical Device (CMD).

Interventions

  • Device: Connected Medical Device
    • Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
  • Device: Traditional transmission system
    • Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room

Arms, Groups and Cohorts

  • Experimental: Connected Medical Device
    • “SMART ANGEL Intra-hospital” System ‘s Connected Medical Device (DMC) measuring physiological parameters in the operating room
  • Active Comparator: Traditional system
    • Traditional wired transmission system between the sensor and the data processing device in the operating room

Clinical Trial Outcome Measures

Primary Measures

  • Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the “SMART ANGEL intra-hospital” system
    • Time Frame: at 2 hours

Secondary Measures

  • Evaluation of missing data due to device malfunction
    • Time Frame: at 2 hours
  • Nurse satisfaction (System Usability Scale)
    • Time Frame: at 2 hours
  • Occurrence of events during the course of the study
    • Time Frame: at 2 hours
  • Time needed by the nursing staff to set up the system
    • Time Frame: at 2 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years – Patients receiving a non-ambulatory surgical or interventional procedure lasting more than 2 hours – Affiliation with a social security syste, beneficiarie or eligible people (excluding State Medical Assistance (AME)) – Written consent of the patient Exclusion Criteria:

  • Patient carrying a multi-resistant germ and placed in isolation – Patient's known linguistic inability to understand the study – Non-ambulatory surgical or interventional act in an emergency situation – Patients under legal protection : curatorship or guardianship – Known pregnancy or nursing woman – Patients with implantable cardiac pacemakers, implantable defibrillators or neurostimulators

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Evolucare Technologies
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Louis MARTY, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris
  • Overall Contact(s)
    • Jean-Louis MARTY, MD, PhD, 01 49 81 43 45, jean.marty@aphp.fr

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