Observational Study of Electrical Impedance Tomography for Non-Invasive Assessment of Cerebral Autoregulation in Neurocritical Patients

NCT07602114 | Not Yet Recruiting

• 1 other identifier: KY20262178-C-1
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, prospective, observational, self-controlled clinical study conducted at the Neurosurgical Intensive Care Unit of Xijing Hospital, The First Affiliated Hospital of Air Force Military Medical University. The study aims to evaluate whether non-invasive Electrical Impedance Tomography (EIT) can reliably assess cerebral blood flow autoregulation in neurocritically ill participants, by comparing EIT-derived parameters with the current gold-standard invasive index PRx. Cerebral blood flow autoregulation helps maintain stable brain perfusion in critically ill neurological patients. Impaired autoregulation raises the risk of secondary brain injury. The current standard evaluation requires invasive intracranial pressure monitoring, which carries risks of infection, bleeding, and tissue damage. EIT is a non-invasive, radiation-free bedside monitoring technique that uses scalp electrodes to measure real-time changes related to cerebral blood flow, with no additional harm to participants. Adult participants admitted to the neurosurgical intensive care unit who require routine invasive intracranial pressure monitoring will be enrolled, with informed consent provided by legal guardians. All participants receive standard clinical care as prescribed by current medical guidelines; no extra experimental treatments, drugs, or invasive procedures are applied for this study. During the study, invasive monitoring data and non-invasive EIT brain monitoring data will be collected simultaneously. Researchers will analyze the correlation and consistency between EIT-derived parameters and the gold-standard index. This study has received ethical approval from the Medical Ethics Committee of The First Affiliated Hospital, Air Force Military Medical University. All participant information is anonymized to protect privacy, and adverse events will be recorded and reported in accordance with regulatory requirements. The results are expected to support a safe, non-invasive monitoring method for cerebral blood flow autoregulation in neurocritical care.

Conditions

Homeostasis

Outcome Measures

Primary Outcomes (1)

• Correlation and consistency between EIT-derived parameters and pressure reactivity index (PRx) for cerebral blood flow autoregulation assessment

  To evaluate the linear correlation (Pearson correlation coefficient) and agreement (Bland-Altman analysis) between non-invasive EIT-derived parameters and the invasive gold-standard PRx index in assessing cerebral blood flow autoregulation among neurocritically ill patients.

  Throughout the neurosurgical intensive care unit stay of participants

Interventions

Non-invasive cerebral Electrical Impedance Tomography (EIT) monitoring OTHER

Non-invasive real-time cerebral physiological monitoring performed by attaching standard scalp electrodes and collecting continuous cerebral bio-impedance signals via an Electrical Impedance Tomography (EIT) system. This monitoring is conducted synchronously with routine invasive intracranial pressure and arterial blood pressure monitoring in neurocritical care. It is purely an observational measurement procedure without any therapeutic intervention or modification to standard clinical treatment for participants, aiming to derive EIT-based parameters for evaluating cerebral blood flow autoregulation function.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult neurocritical care inpatients admitted to the Neurosurgical Intensive Care Unit (NICU) of Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University. Eligible participants are patients aged ≥18 years with severe acute cerebrovascular diseases, severe traumatic brain injury and other critical central nervous system disorders who require NICU admission and routine invasive intracranial pressure and mean arterial pressure monitoring, forming a single-center prospective observational cohort with consecutive enrollment.

You may qualify if:

• Aged ≥18 years old
• Diagnosed with acute intracerebral hemorrhage, subarachnoid hemorrhage or ischemic stroke, admitted to the Neurosurgical Intensive Care Unit
• Receiving routine invasive monitoring of intracranial pressure (ICP) and mean arterial pressure (MAP)
• Written informed consent obtained from the legally authorized representative

You may not qualify if:

• Severe scalp damage, infection or skull defect affecting electrode placement
• Craniotomy history with metal implants interfering with EIT signal acquisition Pregnancy
• Terminal critical illness with estimated survival \<24 hours
• Severe coagulation dysfunction or confirmed allergy to electrode materials
• Unavailable for ≥2-hour continuous valid monitoring data collection

Sponsors & Collaborators

• Xijing Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share