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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02197-50 | Other Identifier | N° IDRCB |
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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 a Connected Medical Device (CMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connected Medical Device | Experimental | "SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room |
|
| Traditional system | Active Comparator | Traditional wired transmission system between the sensor and the data processing device in the operating room |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected Medical Device | Device | Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room |
| 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 |
| 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 |
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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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris - CHU Henri Mondor | Créteil | 94 010 | France |
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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.
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| Traditional transmission system | Device | Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room |
|
| at 2 hours |
| Time needed by the nursing staff to set up the system | at 2 hours |