Evidence map›Paper›PMID 38409283›Full record

Trial reportActa neurochirurgica2024

A pilot clinical study to estimate intracranial pressure utilising cerebral photoplethysmograms in traumatic brain injury patients.

Maria Roldan, Tomas Ysehak Abay, Christopher Uff, Panayiotis A Kyriacou

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Acta neurochirurgica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05632302 nacompletednot on this map

A Pilot Study to Estimate Intracranial Pressure Noninvasively in Traumatic Brain Injury Patients

TypeinterventionalSponsorCrainio LtdaRan2020 to 2021Enrolled40ConditionsTraumatic Brain Injury, Intracranial HypertensionArmsnICP
NCT06453733 narecruitingnot on this mapstarted 2025, after this paper: background citation

Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development

TypeinterventionalSponsorCrainio LtdaRan2025 to 2026Enrolled54ConditionsTraumatic Brain InjuryArmsCrainio
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Maria RoldanResearch Centre for Biomedical Engineering, School of Science & Technology, University of London, London, EC1V 0HB, UK. maria.roldan@city.ac.uk.ORCID 0000-0002-7298-813X
Tomas Ysehak AbayResearch Centre for Biomedical Engineering, School of Science & Technology, University of London, London, EC1V 0HB, UK.ORCID 0000-0002-9096-7551
Christopher UffBarts Health NHS Trust: Royal London Hospital, E1 1BB, London, UK.ORCID 0000-0001-9787-8001
Panayiotis A KyriacouResearch Centre for Biomedical Engineering, School of Science & Technology, University of London, London, EC1V 0HB, UK.ORCID 0000-0002-2868-485X
City, University of London · GBBarts Health NHS Trust · GB

Funding

NIHR BioResource II-LA-0216-20005
6 · The paper itself

Abstract

purposeIn this research, a non-invasive intracranial pressure (nICP) optical sensor was developed and evaluated in a clinical pilot study. The technology relied on infrared light to probe brain tissue, using photodetectors to capture backscattered light modulated by vascular pulsations within the brain's vascular tissue. The underlying hypothesis was that changes in extramural arterial pressure could affect the morphology of recorded optical signals (photoplethysmograms, or PPGs), and analysing these signals with a custom algorithm could enable the non-invasive calculation of intracranial pressure (nICP).

methodsThis pilot study was the first to evaluate the nICP probe alongside invasive ICP monitoring as a gold standard. nICP monitoring occurred in 40 patients undergoing invasive ICP monitoring, with data randomly split for machine learning. Quality PPG signals were extracted and analysed for time-based features. The study employed Bland-Altman analysis and ROC curve calculations to assess nICP accuracy compared to invasive ICP data.

resultsSuccessful acquisition of cerebral PPG signals from traumatic brain injury (TBI) patients allowed for the development of a bagging tree model to estimate nICP non-invasively. The nICP estimation exhibited 95% limits of agreement of 3.8 mmHg with minimal bias and a correlation of 0.8254 with invasive ICP monitoring. ROC curve analysis showed strong diagnostic capability with 80% sensitivity and 89% specificity.

conclusionThe clinical evaluation of this innovative optical nICP sensor revealed its ability to estimate ICP non-invasively with acceptable and clinically useful accuracy. This breakthrough opens the door to further technological refinement and larger-scale clinical studies in the future.

trial registrationNCT05632302, 11th November 2022, retrospectively registered.

Indexed as

Brain Injuries, TraumaticIntracranial HypertensionHumansIntracranial PressureMonitoring, PhysiologicPhotoplethysmographyPilot ProjectsCerebral photoplethysmogramsIntracranial pressureMachine learningNon-invasive monitoringTraumatic brain injury

Identifiers

PMID38409283
PMCPMC10896864
OpenAlexW4392194493

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.