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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Procedure: Optic nerve sheath diameter measured by transorbital ultrasound

Detailed Description

Additional relevant MeSH terms:

cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Štefan Volovár, MUDr.; Phone Number: +420377103120; Email: VOLOVARS@fnplzen.cz
• Study Contact Backup: Name: Milan Hromádka, doc., MUDr., Ph.D.; Phone Number: +420377103120; Email: hromadkam@fnplzen.cz

Study Locations

• Czechia
  • Plzen, Czechia
    • Recruiting
    • University Hospital Plzen
    • Contact: Štefan Volovár, MUDr.; Phone Number: +420377103120; Email: VOLOVARS@fnplzen.cz
    • Contact: Milan Hromádka, doc., MUDr., Ph.D.; Phone Number: +420377103120; Email: hromadkam@fnplzen.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction	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.	96 hours
Comparison of ONSD measurements by ultrasonography and computed tomography	Assessment of accuracy of the optic nerve sheath diameter measured by ultrasonography compared to CT measurement performed 48 ± 12 hours after achievment of ROSC.	48 hours
Correlation between ONSD and fundoscopic signs of papillary edema	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.	48 hours
Correlation between ONSD and thickness of retinal nerve fibers measured by OCT	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 months
Effect of blood carbon dioxide on ONSD	Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and paCO2 and ETCO2 values at the time of measurement.	72 hours
Value of ONSD for long-term neurological outcome and mortality	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.	6 months
Correlation between blood NSE, copeptin and selected RNAs	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.	6 months

Collaborators and Investigators

• Sponsor: University Hospital Pilsen
• Collaborators: University Hospital Olomouc; Na Homolce Hospital
• Investigators: Principal Investigator: Štefan Volovár, MUDr., University Hospital Plzen

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): January 4, 2024
• Study Completion (Anticipated): January 4, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: UHPlisen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No