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Cerebral Autoregulation and Delirium Study (AUTO-POD)

22. juni 2026 opdateret af: University Health Network, Toronto

Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study

Approximately one in four elderly patients develops postoperative delirium (POD) after cardiac surgery. POD is associated with prolonged hospitalization, increased mortality, and higher health care costs. While patient-related risk factors are often difficult to modify, surgery- and anesthesia-related factors may be optimized to reduce the incidence of POD. One potentially modifiable factor is intraoperative blood pressure management. Current practice commonly relies on standardized blood pressure targets during cardiac surgery; however, this "one-size-fits-all" approach may not account for individual variability in cerebral perfusion requirements. This study proposes a personalized blood pressure management strategy based on real-time monitoring of cerebral autoregulation, with the goal of maintaining optimal cerebral perfusion and protecting the brain from both hypo- and hyper-perfusion

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary aim of this pilot study is to evaluate the feasibility of conducting a subsequent definitive trial by assessing recruitment rates, protocol adherence, and the completeness and quality of short-term outcome data collection. The pilot study will also provide an opportunity to identify potential challenges and optimize the design of the larger trial, if necessary.

If the study hypothesis is confirmed and subsequently reproduced in larger, rigorous clinical trials, the findings could have important implications for intraoperative blood pressure management in elderly patients undergoing cardiac surgery. Specifically, this research may support a transition from the current "one-size-fits-all" blood pressure management strategy toward an individualized, real-time approach guided by cerebral autoregulation monitoring. Such a personalized strategy could potentially reduce the incidence of postoperative delirium (POD) in this high-risk population.

Conversely, premature implementation of personalized blood pressure management based solely on the currently available preliminary evidence may lead to unintended adverse consequences. Therefore, the proposed pilot study is essential to provide critical feasibility and safety data before proceeding to a larger definitive trial.

This study will be conducted as a prospective, single-centre, randomized controlled clinical trial comparing a real-time cerebral autoregulation monitoring-based blood pressure management strategy with standard care. Participants will be randomized into two groups:

Intervention Group: Blood pressure management guided by real-time cerebral autoregulation monitoring.

Control Group: Standard intraoperative blood pressure management according to current institutional practice.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

• Consenting patients aged ≥ 60 years undergoing elective complex cardiac surgery (coronary artery bypass grafting plus valve surgery, double-valve surgery, triple-valve surgery, redo operations, or aortic arch surgery), or patients aged ≥ 70 years undergoing isolated coronary artery bypass grafting or single-valve repair/replacement surgery.

Exclusion Criteria:

  • Patients with symptomatic cerebrovascular disease.
  • History of delirium.
  • Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score < 10).
  • Schizophrenia.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Group:

Participants randomized to the intervention group will receive individualized intraoperative blood pressure management guided by real-time cerebral autoregulation monitoring to protect against both hypo- and hyper-cerebral perfusion.

Cerebral autoregulation will be assessed using the cerebral blood volume reactivity index (VRx), defined as the Pearson correlation coefficient between blood volume index (BVI) and mean arterial pressure (MAP). The lower and upper limits of autoregulation will be identified as the MAP values at which VRx exceeds 0.3.

If VRx remains outside the autoregulatory range for more than 60 seconds, the anesthesiologist may intervene to restore MAP within the individualized autoregulatory zone. The type and sequence of interventions will be at the discretion of the attending anesthesiologist.
Enhed: Mespere NeuroOs (Mespere Life Sciences) monitor
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.
Aktiv komparator: Control Group:
In the control group, the cerebral oximetry monitor will be electronically blinded, although data will be continuously recorded for subsequent analysis. Intraoperative blood pressure management will follow current institutional standard practice at the discretion of the attending anesthesiologist.
Enhed: Mespere NeuroOs (Mespere Life Sciences) monitor
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: 2 year
1. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: >10%).
2 year
Non-adherence with the protocol
Tidsramme: 2 year
Non-adherence with the protocol (percentage of patients with VRx > 0.3 where no intervention was performed; <10%)
2 year
Completeness and quality of POD assessment
Tidsramme: 2 year
Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; > 90%)
2 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall incidence of impaired cerebral autoregulation
Tidsramme: 2 year
Overall incidence of impaired cerebral autoregulation in the intervention and control groups.
2 year
Percentage of patients in whom attempted restoration
Tidsramme: 2 year
Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
2 year
The number of interventions required
Tidsramme: 2 year
The number of interventions required to restore VRx to autoregulation range
2 year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tertiary Outcomes: . Frequency of POD
Tidsramme: 2 year
Frequency of postoperative delirium (POD) up to postoperative day 3 in both study groups (primary outcome for the definitive trial).
2 year
Tertiary Outcomes: A composite outcome of major end organ dysfunction
Tidsramme: 2 year
A composite outcome of major end organ dysfunction defined as major organ morbidity and mortality (MOMM) and all cause 30-day mortality.
2 year
Tertiary Outcomes: Postoperative quality of recovery
Tidsramme: 2 year
Postoperative quality of recovery score QoR-15 survey will be performed at baseline, and postoperative days 1 to 3 (or discharge if earlier).
2 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Health Network, Toronto

Efterforskere

  • Ledende efterforsker: George Djaiani, Toronto General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-5746

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

No plan yet

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