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BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine

A legfontosabb adatok

Ki végzi
Scienceforbrain, UAB
Hol
Chicago (Egyesült Államok)A helyszín megnézéseMég 3 másik országban, 3 helyszínen
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
304 fő, tervezett
Kezdés
2026. szept. 30.
Várható befejezés
2027. dec. 30.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • BrainProtect System
  • Standard perioperative management
A regiszteradat frissítve
2026. október 14.

Ki vehet részt

Életkor
18 év – 69 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

  • Age 18-69 years
  • Patient has provided written informed consent to participate in the study
  • Qualification for the elective coronary artery bypass graft (CABG) surgery requiring CPB

Ki nem vehet részt

  • Patients with cognitive impairments which could be associated with POD were diagnosed prior to surgery
  • Patients who are receiving psychotropic medications
  • Patients with an eye disease that may affect monitoring results, as determined by the Investigator
  • Patients who have acute or chronic but currently exacerbated respiratory disease
  • Patients with uncompensated cardiovascular diseases (II-III AV block or cardiogenic shock)
  • Patients with a history of clinically significant neurological or cognitive disorders that may interfere with neurocognitive assessment, including dementia, Alzheimer's disease, Parkinson's disease, or recurrent or persistent delirium within the last 12 months
  • Female subjects who are pregnant or breastfeeding
  • Patient who had an orbital or eye injury
  • It is not possible to perform a qualitative neuropsychological assessment due to other factors (e.g., hearing or vision impairments)

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 69 év között vagy?

Helyszínek itt: Egyesült Államok

Még 3 másik országban, 3 helyszínen

  • Northwestern Memorial HospitalChicago, Egyesült ÁllamokContact: Richa Dhawan, Dr.Toborzás még nem indult

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants undergoing elective coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB).

A teljes eredeti leírásKevesebb

The investigation aims to verify the claim that real-time detection and correction of cerebral autoregulation (CA) impairment during CPB improves neurological outcomes compared to standard perioperative management. The study is designed to demonstrate superiority of BrainProtect-guided management over standard care.

This is a Multicenter, two-arm, blinded, randomized controlled pivotal (confirmatory) clinical investigation of a non-CE marked investigational medical device. Adult participants undergoing elective coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) will be randomized in a 1:1 ratio to either the investigational group or the control group.

In the investigational group, standard perioperative management during CABG with CPB will be performed. Real-time cerebral autoregulation (CA) monitoring using the BrainProtect System will be applied during CPB.

In the control group, standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. The BrainProtect System will not be used, and no real-time cerebral autoregulation monitoring data will be available to the clinical team.

Postoperative neurological outcomes (POCD and POD) will be assessed in both groups using predefined standardized neuropsychological tests and CAM-ICU assessments during the early postoperative period. In addition, the length of the index hospitalisation and occurrence of hospital readmission within 31 days after surgery and the reason for readmission will be recorded.

A vizsgálat 2 csoportja

  • Investigational Group (BrainProtect-guided monitoring)A vizsgált kezelés

    Standard perioperative management during CABG with CPB will be performed. Real-time cerebral autoregulation (CA) monitoring using the BrainProtect System will be applied during CPB. After induction of general anaesthesia according to the standard clinical practice of the participating site, the participant will be placed under controlled ventilation and prepared for cardiac surgery. Once the participant is stabilised under anaesthesia, the Archimedes 02 monitoring system will be positioned on the participant's closed eyelids to enable non-invasive monitoring of intracranial pressure pulse waves and cerebral autoregulation related signals. Cardiopulmonary bypass (CPB) will then be initiated using the heart-lung machine (HLM) according to the routine surgical protocol. Following initiation of CPB and confirmation of stable extracorporeal circulation, the BrainProtect Plug-in Modulator will be activated. Rectangular flow modulation will be initiated after stabilization of CPB parameters

    Kezelés: BrainProtect System és Standard perioperative management

  • Control GroupMár használt kezelés, összehasonlításként

    Standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. Adjunctive cerebral oxygenation monitoring using near-infrared spectroscopy (NIRS) may be used if routinely applied at the site. The BrainProtect System will not be used, and no real-time cerebral autoregulation monitoring data will be available to the clinical team. Blood pressure management will be performed according to standard institutional protocols without CA-guided intervention.

    Kezelés: Standard perioperative management

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery Requiring Heart-lung Machine ("BrainProtect")
Illeszkedési kérdések
Forrás: NCT07872982: ki vehet részt
A regiszteradat frissítve
2026. október 14.