Clinical trial NCT04838418: Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest
Official title: Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest (TOMCAT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Arrest
Lead sponsor: University Hospital Pilsen
Sponsor class: OTHER
Collaborators: name: Na Homolce Hospital
First posted: 2021-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients after cardiac arrest with subsequent ROSC, 18 years of age and older

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.

Detailed description: Additional relevant MeSH terms:

cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

Eligibility 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

Primary outcomes:
measure: Value of ONSD for short-term neurological outcome prediction
timeFrame: 30 days
measure: Value of ONSD for short-term mortality prediction
timeFrame: 30 days
Secondary outcomes:
measure: Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction
timeFrame: 96 hours
measure: Comparison of ONSD measurements by ultrasonography and computed tomography
timeFrame: 48 hours
measure: Correlation between ONSD and fundoscopic signs of papillary edema
timeFrame: 48 hours
measure: Correlation between ONSD and thickness of retinal nerve fibers measured by OCT
timeFrame: 5 months
measure: Effect of blood carbon dioxide on ONSD
timeFrame: 72 hours
measure: Value of ONSD for long-term neurological outcome and mortality
timeFrame: 6 months
measure: Correlation between blood NSE, copeptin and selected RNAs
timeFrame: 6 months
Other outcomes:
Locations:
city: Plzen
country: Czechia
facility: University Hospital Plzen
Study officials:
affiliation: University hospital Plzen
name: Štefan Volovár, MUDr.
role: PRINCIPAL_INVESTIGATOR
References: