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

NCT04084054 | Unknown DMC

• 1 other identifier: NL71331.091.19
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Anoxic Coma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasonic measurement of the optic nerve sheath diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

160 subsequent comatose adult patients after cardiac arrest, admitted to the ICU of Rijnstate hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 30019201 BACKGROUND

• Verhulst MMLH, Visser IM, Keijzer HM, de Kruijf NLM, Peters EJG, Wilbers T, Peelen RV, Hofmeijer J, Blans MJ. Additional predictive value of optic nerve sheath diameter for neurological prognosis after cardiac arrest: a prospective cohort study. Ultrasound J. 2023 Dec 8;15(1):46. doi: 10.1186/s13089-023-00344-3.

  PMID: 38063930 DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Marlous Verhulst

CONTACT

+31 (0)88 005 7745; MMLHverhulst@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 10, 2019
• Study Start: December 2, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

NL (1)