Ultrasonic Measurement of the Optic Nerve Sheath Diameter Predicting Outcome After Cardiac Arrest

Post-Anoxic Coma Clinical Trial

— ONSD  

Official title:

Ultrasonic Measurement of the Optic Nerve Sheath Diameter Predicting Outcome After Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04084054
• Other study ID #: NL71331.091.19
• Status: Recruiting
• Start date: December 2, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Rijnstate Hospital
• Contact: Marlous Verhulst
• Phone: +31 (0)88 005 7745
• Email: MMLHverhulst[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale: An important proportion of patients with return of spontaneous circulation (ROSC) after cardiac arrest remain comatose as a result of post anoxic encephalopathy (PAE). Specific treatments to promote cerebral recovery are lacking. Early identification of patients without potential of recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and families. Intensivists currently use a combination of diagnostic measures, including brainstem reflexes, motor response, status myoclonus, SSEP measurements and (increasingly) the EEG. However, together all these measure identify only 20-50% of the patients with severe PAE precluding cerebral recovery. At the moment, there is a high demand for bedside measurements that contribute to the neurological prognostication of comatose patients after cardiac arrest. Non-invasive bedside measurements of the optic nerve sheath diameter (ONSD) using ultrasound hold potential to improve outcome prediction. Objective: To estimate the value and feasibility of repetitive measurements of the ONSD in comatose patients after cardiac arrest. Study design: Prospective cohort study Study population: 160 subsequent comatose adult patients after cardiac arrest, admitted to the ICU of Rijnstate hospital Intervention: In addition to standard treatments, patients will undergo ultrasonic measurements of the ONSD during the first 3 days after cardiac arrest. Survivors will be followed upon hospital discharge. ONSD measurements will be followed over time and related tot neurological outcome. Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined using the Cerebral Performance Category (CPC) score at 6 months. CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Cardiac arrest
• Admitted to the ICU with Glasgow Coma Scale = 8

Exclusion Criteria:

• Pregnancy
• Traumatic head injury
• Eye surgery in medical history, including cataract surgery
• Pre-existing dependency in daily living (CPC 3 or 4)
• Any known progressive brain illness, such as a brain tumour or neurodegenerative disease

Related Conditions & MeSH terms

• Heart Arrest
• Post-Anoxic Coma

Intervention

Diagnostic Test:
• Ultrasound
Ultrasonic measurement of the optic nerve sheath diameter

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Coma Scale	Neurological outcome, defined using the Cerebral Performance Category (CPC). CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.	At 6 months after cardiac arrest