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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB | Other Identifier | 2021-A01759-32 |
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| Name | Class |
|---|---|
| Evolucare Technologies | INDUSTRY |
| InES - Innovation Electronic Software | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active alerts | Experimental | "SMART ANGEL Intra-hospital" System with active alerts |
|
| Inactive alerts | Active Comparator | "SMART ANGEL Intra-hospital" System with inactive alerts |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active "SMART ANGEL" solution | Device | Nurse intervention according to the alert level + traditional monitoring |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Louis MARTY, MD,PHD | Contact | 01 49 81 43 45 | +33 | jean.marty@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis MARTY, MD,PHD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris - CHU Henri Mondor | Créteil | 94010 | France |
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| Inactive "SMART ANGEL" solution | Device | No alert + traditional monitoring + alert in case of imminent life threat |
|
| 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 |