Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

Cardiac Arrest Clinical Trial

— TOMCAT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04838418
• Other study ID #: UHPlisen
• Status: Active, not recruiting
• Start date: January 4, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: University Hospital Pilsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Additional relevant MeSH terms:

cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Procedure:
• Optic 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.

Locations

Country	Name	City	State
Czechia	University Hospital Plzen	Plzen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Pilsen	Na Homolce Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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