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Completed
NCT05632302
A Non-invasive Intracranial Pressure (nICP) Monitoring System
Conditions: Traumatic Brain Injury, Intracranial Hypertension
Sex: All
Ages: 16 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Crainio Ltda
Location: United Kingdom
Summary
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe.
Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries.
Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously.This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available.
The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment.Features of the optical signals would be analysed offline.
A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.
Eligibility Criteria
Inclusion Criteria:Patient admitted to the Royal London Hospital who is having invasive ICP monitoring as part of their normal medical careSubject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent.
If the patient is unconscious, and a consultee is not available then a professional consultee (a doctor looking after the patient who is not involved in the trial) will assent to inclusion in the trial and non-invasive ICP monitoring will be performed.Exclusion Criteria:Patients with decompressive craniectomy
Source: ClinicalTrials.gov (NCT05632302). StuddyBuddy aggregates publicly available trial information.