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

NCT06594198 | Completed DMC

• 1 other identifier: 2024-A00125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Monitor; Anaesthesia

Keywords

Brain Monitor; ARGOS Platform; SctO2; ANI; bcSEF; EEG bispectral index; Cerebral tissue oxygen saturation; Analgesia Nociception Index

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• ANI and Database

  During the surgical procedure

Study Arms (1)

One center and 40 patients

EXPERIMENTAL

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

Device: Cerebral monitor

Interventions

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.

One center and 40 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braindex: lead
• Clinique de la Sauvegarde: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-centre, prospective, interventional clinical study

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion: September 9, 2024
• Study Completion: March 3, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)