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OpenTrials
Completed

NCT Number: NCT06594198

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Comparison of SctO2 values from ARGOS and INVOS

    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.

Secondary outcomes

  1. ANI and Database

    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.

Sponsors and collaborators

Lead sponsor

Braindex

Industry

Collaborators

  • Clinique de la Sauvegarde

Registry information

Acronym: ARGOS Platform

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
May 16, 2025

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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