Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest

Cardiac Arrest Clinical Trial

— ONSD-CA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513628
• Other study ID #: MelunH
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: July 30, 2015
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2015
• Source: Hopital of Melun
• Contact: n/a
• Is FDA regulated: No
• Health authority: FRANCE: French Intensive Care Society
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hopital of Melun

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	participants will be followed for the duration of hospital stay, an expected average of 3 months.	3 months	No