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Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest (TOMCAT)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04838418
Acronym
TOMCAT
Enrollment
80
Registered
2021-04-09
Start date
2021-01-04
Completion date
2026-12-01
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief summary

In sudden cardiac arrest patients with return of spontaneous circulation, brain damage is one of the main determinants of short-term mortality and poor prognosis (CPC 3-5). It is important to properly select group of patients in whom treatment is futile. According to current guidelines, multimodal approach is recommended. Optic nerve sheath diameter measured by ultrasound is non-invasive, fast, low-cost and readily available bed-side method, but evidence for its use as neuroprognostication modality is limited to only few small studies. The aim of this study is to evaluate validity of ONSD as neuroprognostication method at larger cohort of patients, compare it with other established methods and compare ultrasound and CT measurement of ONSD.

Detailed description

Additional relevant MeSH terms: cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

Interventions

PROCEDUREOptic nerve sheath diameter measured by transorbital ultrasound

Optic nerve sheath diameter measured 3 mm behind eyeball. For every eyeball 2 measurements in axial and 2 measurements in sagital projections are performed. Summary value for every eyeball is arithmetic mean from these 4 measurements.

Sponsors

University Hospital Pilsen
Lead SponsorOTHER
Na Homolce Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age of 18 years or older * out of hospital cardiac arrest of non-traumatic cause with CPR and subsequent ROSC * Glasgow coma scale (GCS) ≤ 7 or sedation 30 minutes after ROSC achievment

Exclusion criteria

* unavailable first measurment of the optic nerve sheath diameter (ONSD) measured by transorbital ultrasonography 24±6 hours after ROSC achievement * refractory cardiac arrest * craniocerebral injury * intracranial tumor * active intracranial bleeding * haemorrhagic stroke and/or subarachnoid haemorrhage in the last 3 months * facial trauma affecting the eye area * active neuroendocrine tumor, small cell lung cancer, non-small cell lung * CPC 3-5 before cardiac arrest * sclerosis multiplex and/or optic neuritis of other etiology

Design outcomes

Primary

MeasureTime frameDescription
Value of ONSD for short-term neurological outcome prediction30 daysAssessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and neurological outcome of patients (quantified by the CPC scale) after out of hospital cardiac arrest with subsequent ROSC
Value of ONSD for short-term mortality prediction30 daysAssessment of the correlation between optic nerve sheath diameter measured by transorbital ultrasonography and mortality during a 30-day follow-up.

Secondary

MeasureTime frameDescription
Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction96 hoursAssessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and negative prognostic markers obtained by somatosensory evoked potentials examination and EEG in patients remaining in a coma even after the end of therapeutic hypothermia and sedation.
Comparison of ONSD measurements by ultrasonography and computed tomography48 hoursAssessment of accuracy of the optic nerve sheath diameter measured by ultrasonography compared to CT measurement performed 48 ± 12 hours after achievment of ROSC.
Correlation between ONSD and fundoscopic signs of papillary edema48 hoursAssessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and grade of optic nerve papillary edema quantified by the Frisen scale on fundoscopic examination performed 48 ± 12 hours after achievment of ROSC.
Correlation between ONSD and thickness of retinal nerve fibers measured by OCT5 monthsAssessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and thickness of retinal nerve fibers measured by optical coherence tomography at time intervals of 1, 3 and 5 months after achievment of ROSC.
Effect of blood carbon dioxide on ONSD72 hoursAssessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and paCO2 and ETCO2 values at the time of measurement.
Value of ONSD for long-term neurological outcome and mortality6 monthsAssessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and mortality and neurological outcome of patients (quantified by the CPC scale) at 6 months after ROSC.
Correlation between blood NSE, copeptin and selected RNAs6 monthsAssessment of the correlation between blood NSE, copeptin and selected micro-RNAs measured at defined time intervals from ROSC, to neurological outcome prediction in patients after out of hospital cardiac arrest with subsequent ROSC.

Countries

Czechia

Contacts

PRINCIPAL_INVESTIGATORŠtefan Volovár, MUDr.

University hospital Plzen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026