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Status unknownNCT04084054ONSDUpdated Oct 26, 2022

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

An observational study in Post-Anoxic Coma, sponsored by Rijnstate Hospital. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Rijnstate Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Post-Anoxic Coma

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In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 160 is below the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testUltrasound

    Ultrasonic measurement of the optic nerve sheath diameter

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What researchers measure

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.

    Time frame: At 6 months after cardiac arrest

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Study locations

1 of 1 sites recruiting
  • Rijnstate Hospital
    Arnhem, Gelderland 6815 AD, Netherlands
    Recruiting
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References and documents

Publications

  • 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. PubMed 30019201 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04084054
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
Sep 10, 2019
Start date
Dec 2, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 26, 2022

Study contacts

Marlous Verhulst
Contact
MMLHverhulst@rijnstate.nl
+31 (0)88 005 7745

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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