Not Yet RecruitingNot Applicable

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

100 participantsStarted 2026-05-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT07602114

SponsorXijing Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-28

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