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

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ClinicalTrials.gov Identifier: NCT04838418
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Pilsen

Study Description
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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.

Condition or disease
Assessment of the Correlation Between the Optic Nerve Sheath Diameter Cardiac Arrest

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest (TOMCAT)
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : January 4, 2024
Estimated Study Completion Date : January 4, 2024

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 1.) Value of ONSD for short-term neurological outcome prediction [ Time Frame: 30 days ]
    1.) o 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. 2.) Value of ONSD for short-term mortality prediction [ Time Frame: 30 days ]
    2.) Assessment of the correlation between optic nerve sheath diameter measured by transorbital ultrasonography and mortality during a 30-day follow-up.

  3. 3.) Assessment of the correlation [ Time Frame: 6 months ]
    3.) 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.


Secondary Outcome Measures :
  1. 1.) Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction [ Time Frame: 96 hours ]
    1.) 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. 2.) Comparison of ONSD measurements by ultrasonography and computed tomography [ Time Frame: 48 hours ]
    2.) 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. 3.) Correlation between ONSD and fundoscopic signs of papillary edema [ Time Frame: 48 hours ]
    3.) 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. 4.) Correlation between ONSD and thickness of retinal nerve fibers measured by OCT [ Time Frame: 5 months ]
    4.) 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. 5.) Effect of blood carbon dioxide on ONSD [ Time Frame: 72 hours ]
    5.) 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. 6.) Value of ONSD for long-term neurological outcome and mortality [ Time Frame: 6 months ]
    6.) 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Caucasians
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838418


Contacts
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Contact: Štefan Volovár, MUDr. +420377103573 VOLOVARS@fnplzen.cz
Contact: Milan Hromádka, MUDr. Ph.D. +420377103573 hromadkam@fnplzen.cz

Locations
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Czechia
University Hospital Plzen Recruiting
Plzen, Czechia
Contact: Štefan Volovár    +420377103573    VOLOVARS@fnplzen.cz   
Contact: Milan Hromádka    +420377103573    hromadkam@fnplzen.cz   
Sponsors and Collaborators
University Hospital Pilsen
Investigators
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Principal Investigator: Štefan Volovár, MUDr. University hospital Plzen
More Information
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Responsible Party: University Hospital Pilsen
ClinicalTrials.gov Identifier: NCT04838418    
Other Study ID Numbers: UHPlisen
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases