Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

NCT04838418 | Active Not Recruiting

• 1 other identifier: TOMCAT
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

• Value of ONSD for short-term neurological outcome prediction

  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

  30 days

• Value of ONSD for short-term mortality prediction

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

  30 days

Secondary Outcomes (7)

• Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction

  96 hours

• Comparison of ONSD measurements by ultrasonography and computed tomography

  48 hours

• Correlation between ONSD and fundoscopic signs of papillary edema

  48 hours

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

  5 months

• Effect of blood carbon dioxide on ONSD

  72 hours

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients after cardiac arrest with subsequent ROSC, 18 years of age and older

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Pilsen: lead
• Na Homolce Hospital: collaborator

Study Sites (1)

University Hospital Plzen

Pilsen, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

microRNA, copeptine and NSE sampling

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Štefan Volovár, MUDr.

  University hospital Plzen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: January 4, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)