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NCT Number: NCT04838418

Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Plzen

Pilsen, Czechia

About this study

Additional relevant MeSH terms:

cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optic nerve sheath diameter measured by transorbital ultrasound

Procedure

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.

Primary outcomes

  1. Value of ONSD for short-term neurological outcome prediction

    Time frame: 30 days

    Assessment 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

  2. Value of ONSD for short-term mortality prediction

    Time frame: 30 days

    Assessment of the correlation between optic nerve sheath diameter measured by transorbital ultrasonography and mortality during a 30-day follow-up.

Secondary outcomes

  1. Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction

    Time frame: 96 hours

    Assessment 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.

  2. Comparison of ONSD measurements by ultrasonography and computed tomography

    Time frame: 48 hours

    Assessment of accuracy of the optic nerve sheath diameter measured by ultrasonography compared to CT measurement performed 48 ± 12 hours after achievment of ROSC.

  3. Correlation between ONSD and fundoscopic signs of papillary edema

    Time frame: 48 hours

    Assessment 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.

  4. Correlation between ONSD and thickness of retinal nerve fibers measured by OCT

    Time frame: 5 months

    Assessment 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.

  5. Effect of blood carbon dioxide on ONSD

    Time frame: 72 hours

    Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and paCO2 and ETCO2 values at the time of measurement.

  6. Value of ONSD for long-term neurological outcome and mortality

    Time frame: 6 months

    Assessment 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.

  7. Correlation between blood NSE, copeptin and selected RNAs

    Time frame: 6 months

    Assessment 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.

Sponsors and collaborators

Lead sponsor

University Hospital Pilsen

Other

Collaborators

  • Na Homolce Hospital

Registry information

Official study title

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

Acronym: TOMCAT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2021
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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