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Braindex Cerebral Tissue Oxygen Saturation (SctO2) Measurement Algorithm Assessment and Improvement

NCT05897060 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-09

No results posted yet for this study

Summary

The objective of this clinical trial is to optimize Braindex brain tissue oxygen saturation (SctO2) measurement algorithm compared to a mixed reference value of jugular venous and systemic arterial saturation, during proven reproducible and standardized loss of brain autoregulation induced during transcatheter aortic valve replacement procedures. The main question it aims to answer is: assessing and improving the sensitivity/specificity of Braindex SctO2 measurements.

Study type: single-center, prospective, interventional, open-label, exploratory clinical trial.

Participant population/health status:

* Patient, male or female, over 18 years of age
* Patient scheduled for percutaneous femoral aortic valve replacement with aortic valve balloon deployment (Edwards Sapien valve) under simple sedation with Remifentanil (TIVA), with spontaneous ventilation.

The expected outcome of this research is to optimize in vivo the algorithm for calculating the SctO2 of the BRAINDEX sensor in surgical conditions, in a context of proven low cerebral flow, on a target population. It is expected, in the long run, a better quality of detection of the loss of cerebral auto-regulation leading to a faster and optimal correction, thus potentially limiting the risk of POCD, subcortical stroke and postoperative cognitive decline.

Conditions

  • Post-Operative Confusion

Interventions

DEVICE

Venus Jugular O2 Saturation optical fiber

A continuous measurement of VjO2S, the usual reference measurement of the marketed devices, will be performed by implanting an optical fiber (CEVOX, PULSION Medical Systems) through an internal jugular catheter in addition to the classical catheter of the external electro-systolic drive probe. The following parameters will be recorded every 2 seconds: invasive blood pressure (systolic, mean and diastolic), heart rate, SaO2 on the pulse wave. VjO2S will be recorded continuously during the entire implantation procedure. The time of the beginning of the surgical incision, of the beginning of sinus tachycardia (overdriving) induced by external electro-systolic stimulation, of the beginning of inflation of the intravalvular aortic balloon, of the maximum occlusion of the balloon, of the end of complete deflation of the balloon, of the end of stimulation and of the end of skin closure will be recorded.

Sponsors & Collaborators

  • Braindex

    lead INDUSTRY

Principal Investigators

  • Julien AMOUR · Jacques Cartier Private Hospital (Massy - France)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2023-10-30
Completion
2023-10-30

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 NCT05897060 on ClinicalTrials.gov