Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (INSPIRE)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Cardiac Surgery; Silent Brain Infarction; Neuroprotective; Neurocognitive Disorders

Treatments: Other: Managements for institutional routine; Other: Managements for NeuroFirst target bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT07048002

The INSPIRE study

Details and patient eligibility

About

the purpose of the study is to investigate whether a combined anesthetic targets bundle, known as the NeuroFirst strategy, focused on neurological protection, can reduce the incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in patients undergoing cardiac surgery. Additionally, the trial will assess the safety of this strategy.

The NeuroFirst target bundle incorporates multiple parameters, including mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass.

The primary question this study seeks to answer is: Does the NeuroFirst strategy reduce the incidence of SBI and PND in cardiac surgery?

To address this, researchers will compare the NeuroFirst strategy with routine institutional practices based on published guidelines. Participants will be randomly assigned to either the NeuroFirst group or the routine care group. All participants will undergo magnetic resonance imaging (MRI), be assessed using the Confusion Assessment Method (CAM) and the Montreal Cognitive Assessment (MoCA), and be followed for up to one year postoperatively.

Enrollment: 912 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adult patients aged 60 years or older
• Receiving elective cardiovascular surgery with cardiopulmonary bypass
• Written Informed consent provided

Exclusion criteria

• Contraindication to MRI scanning
• Not suitable for receiving interventions to achieve NeuroFirst target bundle
• Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments
• Breastfeeding or pregnancy
• Terminal illness with a life expectancy of less than 3 months
• Mental or legal disability
• current enrollment in other interventional study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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912 participants in 2 patient groups

NeuroFirst target bundle

Experimental group

Description:

Management for NeuroFirst target bundle

Treatment:

Other: Managements for NeuroFirst target bundle

Routine Management

Active Comparator group

Description:

Management for institutional routine in accordance with published guidelines

Treatment:

Other: Managements for institutional routine