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CompletedNCT02513628ONSD-CAUpdated Jul 31, 2015

Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest

An observational study in Cardiac Arrest, sponsored by Hopital of Melun. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Hopital of Melun · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
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Study summary

Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works showed that ONSD measurement could be used to predict outcome in post-CA patients.

The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in post-cardiac arrest patients treated with therapeutic hypothermia (TH).

Read the detailed description

Prospective observational study including all consecutive successfully resuscitated and TH-treated CA patients without traumatic or neurological etiology of CA in two French ICUs. ONSD measurements were performed on day 1, 2, and 3 after return of spontaneous circulation (ONSD1,2,3 respectively).

The primary outcome is survival at hospital discharge (with an average follow-up of 3 month until ICU admission).

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Conditions studied

  • Cardiac Arrest

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Keywords

  • Cardiac arrest
  • neuroprognostication
  • optic nerve sheath diameter
  • outcome
  • ultrasonography
03

In context

Heart Arrest

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

This study's enrollment of 36 is below the median of 196 across 394 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Hopital of Melun is the lead sponsor of 8 studies on the registry; none 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
Probability sample

Study population

All unconscious (Glasgow Coma Scale ≤6) patients ≥18 years old, admitted in ICU after successful resuscitation from CA, and treated with TH targeted to 33°C were screened. Exclusion criteria were as follows: unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability), traumatic or neurological origin of CA, previous cerebrovascular disease, facial trauma affecting the orbits and/or eyeballs, and previous history of ocular pathology such as exophthalmia, glaucoma or cataract.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Unconscious (Glasgow Coma Scale ≤6)
  • ≥18 years old
  • Admitted in ICU after successful resuscitation from CA
  • Treated with TH targeted to 33°C

Exclusion criteria

Exclusion Criteria:

  • unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability)
  • Traumatic or neurological origin of CA
  • Previous cerebrovascular disease
  • Facial trauma affecting the orbits and/or eyeballs
  • Previous history of ocular pathology such as exophthalmia, glaucoma or cataract.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Target follow-up
3 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. In-hospital mortality

    participants will be followed for the duration of hospital stay, an expected average of 3 months.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02513628
Lead sponsor
Hopital of Melun
Responsible party
Chelly Jonathan (MD, Hopital of Melun) — Principal investigator
First posted
Jul 31, 2015
Start date
Nov 2011
Primary completion
Sep 2013
Completion
Jan 2014
Last update
Jul 31, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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