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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Medical Device

Intervention / Treatment
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* Device: Connected Medical Device
* Device: Traditional transmission system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Measurement of 3 constants (SpO2, heart rate and respiratory rate) in patients with a non-ambulatory surgical or interventional act lasting more than 2 hours whose constants are monitored by the reference device in the operating room and the Connected Medical Device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected Medical Device<br>SMART ANGEL Intra-hospital System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room | Device: Connected Medical Device<br>* Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room<br>|
| Active Comparator: Traditional system<br>Traditional wired transmission system between the sensor and the data processing device in the operating room | Device: Traditional transmission system<br>* Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connected Medical Device, Device Feasibility, Post-operative mortality, SMART ANGEL intra-hospital system