NCT02869997

Brief Summary

The aim of this study is to evaluate the prognostic value of the suppression ratio monitored by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient admitted to our intensive care unit after a cardiac arrest are included. The results of the suppression ratio will be collected in the 6 first hours of admission. We will evaluate the link between suppression ratio and cerebral performance category score collected at three months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

August 12, 2016

Last Update Submit

August 12, 2016

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Cerebral Performance Category score

    3 months

Study Arms (1)

Single arm

EXPERIMENTAL

arm wherein all patients Suppression Ratio evaluated by BIS will be collected

Device: Aspect BIS XP (A-2000) Bispectral Index Patient Monitor

Interventions

Aspect BIS XP (A-2000) Bispectral Index Patient MonitorDEVICE
Single arm

Eligibility Criteria

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

You may qualify if:

  • Adult
  • Cardiac arrest admitted to the ICU

You may not qualify if:

  • \- Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • François Belon, MD

    CHRU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 17, 2016

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

May 1, 2017

Last Updated

August 17, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)