Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest (ONSD-CA)

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

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).

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest

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).

• Study Type: Observational
• Enrollment (Actual): 36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	participants will be followed for the duration of hospital stay, an expected average of 3 months.	3 months

Collaborators and Investigators

• Sponsor: Hopital of Melun

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Cardiac arrest; outcome; ultrasonography; optic nerve sheath diameter; neuroprognostication
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: MelunH