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

NCT ID: NCT06594198

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-03-03

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.

Conditions

Brain Monitor; Anaesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

One center and 40 patients

Monitor the values of 3 brain parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor.

Group Type: EXPERIMENTAL

Cerebral monitor

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique de la Sauvegarde

OTHER

Sponsor Role: collaborator

Braindex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de la Sauvegarde

Lyon, , France

Countries

France

Other Identifiers

2024-A00125

Identifier Type: -

Identifier Source: org_study_id