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

NCT05897060 | Unknown

• 1 other identifier: 2022-A02770-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Delirium; NIRS; cognitive decline; elderly; confusion

Outcome Measures

Primary Outcomes (1)

• Optimization of SctO2 Braindex algorithm

  SctO2 which is Tissular Cerebral Saturation in Oxygène expressed in percentage

  Duration of the patient's Trans-catheter Aortic Valve Implantation procedure

Secondary Outcomes (2)

• Validation of Braindex EEG measures

  Duration of the patient's Trans-catheter Aortic Valve Implantation procedure

• Validation of Analgesia Nociception Index (MDoloris) acquired via frontal Braindex frontal PPG

  Duration of the patient's Trans-catheter Aortic Valve Implantation procedure

Study Arms (1)

Patients undergoing TAVI procedure

EXPERIMENTAL

The study is interventional and consists of a single group of patients undergoing a Transcatheter Aortic Valve Implantation (TAVI), receiving in addition to the usual treatment, an optical fiber placed retrograde in the jugular bulb, in order to record the values of SJVO2 every second.

Device: Venus Jugular O2 Saturation optical fiber

Interventions

Venus Jugular O2 Saturation optical fiber DEVICE

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.

Also known as: CEVOX,PULSION Medical Systems

Patients undergoing TAVI procedure

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 to undergo percutaneous femoral aortic valve replacement with aortic valve deployment by balloon (Edwards Sapien valve) under simple sedation with remifentanil in TIVA, with spontaneous ventilation
• Patient affiliated or entitled to a social security plan
• Patient having received written and informed information about the study and having signed a free and free and informed consent to participate in the study.

You may not qualify if:

• Emergency surgery
• Patient weighing less than 40 kg
• Patient with a history of ischemic stroke
• Patient with a contraindication to jugular and arterial catheterization
• Patient with a contraindication to the Braindex device
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, parturient or breastfeeding woman
• Patient hospitalized without consent

Sponsors & Collaborators

• Braindex: lead

Study Sites (1)

Jacques CARTIER Private Hospital

Massy, Île-de-France Region, 91300, France

RECRUITING

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Julien AMOUR

  Jacques Cartier Private Hospital (Massy - France)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry CUSSAC

CONTACT

+33(7)82230369; thierry.cussac@braindex.fr

Pierre CHARLIER

CONTACT

pierre.charlier@braindex.fr

Study Design

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

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 9, 2023
• Study Start: May 11, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-05

Locations

FR (1)