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| Name | Class |
|---|---|
| Clinique de la Sauvegarde | OTHER |
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The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).
SctO2 values from ARGOS and INVOS will be resampled every 30 seconds. The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test. Bias and agreement limits will be assessed using Bland & Altmann graphs. This test will be carried out for the entire duration of the recording.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One center and 40 patients | Experimental | Monitor the values of 3 brain parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral monitor | Device | The study procedure consists of monitoring the values of 3 cerebral parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor. These 3 parameters will be recorded and compared after the intervention with 3 parameters considered as standard: SctO2 measured by the INVOS 7100 cerebral oximeter, the bispectral index (BIS) measured by the BIS monitor and the ANI measured by the MDoloris monitor. These 3 reference parameters are once again usually monitored and recommended for all cardiac surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SctO2 values from ARGOS and INVOS | Compare ARGOS and INVOS SctO2 values at different times of interest during the procedure. Compare ARGOS SctO2 values with invasive central venous and arterial saturation (measured by gasometry) during aortic unclamping. Compare INVOS SctO2 values with central venous and arterial saturation before, during and after aortic unclamping. | During the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| ANI and Database | For ANI: Compare the ANI values of the ARGOS device with the ANI values of the reference device (ANIv2 monitor, MDoloris Medical Systems). For the bcSEF: Compare the bcSEF values of the ARGOS and the BIS values at different characteristic times during the procedure. Build up a database for secondary analysis by continuously recording all data. | During the surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Sauvegarde | Lyon | 69009 | France |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2025 | |
| Reset | Jun 6, 2025 | |
| Release | Jun 9, 2025 | |
| Reset | Jun 25, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2025 | Jun 6, 2025 | |||
| Jun 9, 2025 |
| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Single-centre, prospective, interventional clinical study
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| Jun 25, 2025 |