Cerebral Autoregulation and Delirium Study (AUTO-POD)
Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Deep Grewal
- Número de teléfono: 4221 416-340-4800
- Correo electrónico: deep.grewal@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: George Djaiani, MD FRCAFRCPS
- Número de teléfono: 6205 416-340-4800
- Correo electrónico: george.djaiani@uhn.ca
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.
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|
Comparador activo: 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.
|
bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recruitment rate
Periodo de tiempo: 2 year
|
1. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: >10%).
|
2 year
|
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Non-adherence with the protocol
Periodo de tiempo: 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
Periodo de tiempo: 2 year
|
Completeness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; > 90%)
|
2 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall incidence of impaired cerebral autoregulation
Periodo de tiempo: 2 year
|
Overall incidence of impaired cerebral autoregulation in the intervention and control groups.
|
2 year
|
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Percentage of patients in whom attempted restoration
Periodo de tiempo: 2 year
|
Percentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
|
2 year
|
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The number of interventions required
Periodo de tiempo: 2 year
|
The number of interventions required to restore VRx to autoregulation range
|
2 year
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tertiary Outcomes: . Frequency of POD
Periodo de tiempo: 2 year
|
Frequency of postoperative delirium (POD) up to postoperative day 3 in both study groups (primary outcome for the definitive trial).
|
2 year
|
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Tertiary Outcomes: A composite outcome of major end organ dysfunction
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: George Djaiani, Toronto General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Delirio
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Delirio de emergencia
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Monitoreo, fisiológico
Otros números de identificación del estudio
- 25-5746
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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