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

Not Applicable

Completed

• Conditions: Brain Monitor; Anaesthesia
• Interventions: Device: Cerebral monitor

• Registration Number: NCT06594198
• Lead Sponsor: Braindex

Brief 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.

Study Timeline

• Study Start: 2024-09-09
• Primary Completion: 2024-09-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Study Completion: 2025-03-03
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient, male or female, over 18 years of age
• Patient scheduled for cardiac surgery with programmed extracorporeal circulation (ECC)
• Patient with no history of scalp injury or or skin diseases
• Patient with an Euroscore 2 of less than 7%.
• Patient affiliated or entitled to a social assurance

Exclusion Criteria

• Weight under 40 kg
• Frontal surface too small to allow application of SctO2, BIS electrodes on the same hemifront
• Patient with severe, unbalanced hypertension
• Measurement of systolic blood pressure (SBP) > 180 mm Hg and/or diastolic blood pressure (DBP) > 110 mm Hg
• Patients undergoing emergency surgery
• Patient with chronic renal failure, with glomerular filtration < 30 ml/min/1.73m², or requiring renal transplantation or requiring renal transplantation
• Patient with left ventricular ejection fraction < 40%
• Patient with a history of ischemic stroke
• Patients with preoperative sepsis
• Patient requiring noradrenaline infusion noradrenaline infusion in the 24 hours prior to surgery
• Patient with preoperative uni or bilateral carotid stenosis bilateral carotid stenosis > 50%.
• Protected patient: adult under guardianship, curatorship or legal protection, deprived of liberty by judicial or administrative decision.
• Pregnant, parturient or breast-feeding women.
• Patients hospitalized without consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One center and 40 patients	Cerebral monitor	Monitor the values of 3 brain parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor.

Primary Outcome Measures

Name	Time	Method
Comparison of SctO2 values from ARGOS and INVOS	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.

Secondary Outcome Measures

Name	Time	Method
ANI and Database	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.

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France