Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study (NCT06594198) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
France40 participantsStarted 2024-09-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.