NCT02513628

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

July 24, 2015

Last Update Submit

July 30, 2015

Conditions

Keywords

Cardiac arrestneuroprognosticationoptic nerve sheath diameteroutcomeultrasonography

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

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

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 31, 2015

Study Start

November 1, 2011

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07