Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device

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 the SMART ANGEL Intra-hospital System's (connected medical devices and alerts).

Official Title
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Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )

Conditions
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Medical Device

Intervention / Treatment
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* Device: Active SMART ANGEL solution
* Device: Inactive SMART ANGEL solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients receiving a scheduled non-ambulatory surgical or interventional procedure Affiliation to a social security scheme, beneficiary or entitled person (excluding AME) Patient's written consent or of the trusted person in case of physical incapacity Exclusion Criteria: Inclusion in emergency situations ASA1 patient (without associated pathology) Patient with a multi-drug resistant germ in isolation Known linguistic inability of the patient to understand the study Known pregnancy or breastfeeding woman Patients with implantable pacemakers, implantable defibrillators or neurostimulators. Person under legal protection or unable to give consent Person deprived of liberty by judicial or administrative decision

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active alerts<br>SMART ANGEL Intra-hospital System with active alerts | Device: Active SMART ANGEL solution<br>* Nurse intervention according to the alert level + traditional monitoring<br>|
| Active Comparator: Inactive alerts<br>SMART ANGEL Intra-hospital System with inactive alerts | Device: Inactive SMART ANGEL solution<br>* No alert + traditional monitoring + alert in case of imminent life threat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in response times for nurses | Difference in response times between the two groups as measured by the difference between the exact time of occurrence of the complication and the time of caregiver intervention. | between inclusion visit and day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality during hospitalisation | Within 30 days of the intervention | between inclusion visit and day 30 | 
| Mortality within 30 days of surgery |  | between inclusion visit and day 30 | 
| Percentage of transfers to intensive care unit |  | between inclusion visit and day 30 | 
| Length of stay |  | between inclusion visit and day 30 | 
| ICU length of stay |  | between inclusion visit and day 30 | 
| Rate of calls to the doctor on duty |  | between inclusion visit and day 30 | 
| Percentage of re-hospitalization within 30 days |  | between inclusion visit and day 30 | 
| Percentage of hospitalisations in follow-up care and rehabilitation care units |  | between inclusion visit and day 30 | 
| Percentage of patients managed at home |  | between inclusion visit and day 30 | 
| False positive rate | Alert without complication for the patient | between inclusion visit and day 30 | 
| Incremental cost-effectiveness ratio |  | between inclusion visit and day 30 | 
| Patient acceptability | Quantitative and qualitative assessment of the device's usability by the patient via Questionnaire and interview | between inclusion visit and day 30 | 
| Acceptability of care teams | Questionnaire and interview | between inclusion visit and day 30 | 

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