NCT06594198

Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Braindex · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Brain Monitor
• Anaesthesia

Interventions

Type	Name	Description
DEVICE	Cerebral monitor	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.

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-09-09
• Completion: 2025-03-03
• First posted: 2024-09-19
• Last updated: 2025-05-16

Locations

1 site across 1 country: France