Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD) (SMART-METRO)

Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)

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.

Study Overview

• Status: Unknown
• Conditions: Medical Device
• Intervention / Treatment: Device: Connected Medical Device; Device: Traditional transmission system

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94 010
    • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connected Medical Device; "SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room	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
Active Comparator: Traditional system; Traditional wired transmission system between the sensor and the data processing device 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	at 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Evolucare Technologies; InES - Innovation Electronic Software
• Investigators: Principal Investigator: Jean-Louis MARTY, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Device Feasibility; Connected Medical Device; Post-operative mortality; "SMART ANGEL intra-hospital" system
• Other Study ID Numbers: APHP190708; 2019-A02197-50 (Other Identifier: N° IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No