Clinique de la Sauvegarde
Lyon, 69009, France
NCT Number: NCT06594198
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lyon, 69009, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During the surgical procedure
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.
Time frame: During the surgical procedure
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.
Braindex
Industry
Acronym: ARGOS Platform
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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