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

NCT06594198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Clinique de la Sauvegarde

    collaborator OTHER

  • Braindex

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2024-09-09
Completion
2025-03-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06594198 on ClinicalTrials.gov