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Completed

NCT Number: NCT02513628

Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest

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).

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Hopital of Melun

Other

Registry information

Official study title

The Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest: a Pilot Prospective Study

Acronym: ONSD-CA

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 31, 2015
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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