Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

NCT ID: NCT04838418

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2025-06-01

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.

Conditions

Cardiac Arrest

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Na Homolce Hospital

OTHER

Sponsor Role: collaborator

University Hospital Pilsen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Štefan Volovár, MUDr.

Role: PRINCIPAL_INVESTIGATOR

University hospital Plzen

Locations

University Hospital Plzen

Pilsen, , Czechia

Countries

Czechia

Other Identifiers

TOMCAT

Identifier Type: -

Identifier Source: org_study_id