Can a non-invasive brain monitor using electrical impedance tell us about cerebral blood flow autoregulation in critical neurological patients
Official title: A Clinical Study of Non-Invasive Assessment of Cerebral Autoregulation Using Electrical Impedance Tomography
Run by Xijing Hospital · NCT07602114 · Data updated 2026-11-12
This study tests whether a non-invasive EIT device can see how well the brain keeps blood flow steady in adults with severe brain injuries, by comparing it to the usual invasive method.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | August 25, 2026 |
| Main results expected | February 28, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07602114 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with acute ICH, SAH, or ischemic stroke in the Neuro ICU who already receive invasive ICP and MAP monitoring and have a representative surrogate able to consent.
✕Probably not a fit
Patients without reliable EIT signals or with conditions preventing electrode placement may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, observational study in the Neurosurgical ICU at Xijing Hospital. It evaluates whether electrical impedance tomography (EIT) can reliably reflect cerebral autoregulation by comparing EIT-derived indicators with the gold standard invasive PRx index. The study uses a 16-electrode cerebral EIT system (EC100-PRO) to continuously monitor patients who already have invasive ICP and MAP monitoring. Only adults with acute intracerebral hemorrhage, subarachnoid hemorrhage, or ischemic stroke are included, and consent is provided by a legally authorized representative. Data collection requires at least two hours of uninterrupted monitoring, and patients with contraindications to EIT are excluded. Primary aim is to determine agreement between non-invasive EIT signals and invasive PRx in assessing autoregulation.
Why it matters
Potential benefit: If successful, clinicians could non-invasively monitor cerebral autoregulation at the bedside, potentially reducing risk from invasive monitoring.
How similar studies have gone: Previous work supports non-invasive approaches to monitor cerebral physiology, but direct validation against PRx in this exact setting remains limited and this study adds prospective observational data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.