Cerebral Oxygenation in Cardiac Arrest and Hypothermia

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: near infrared spectroscopy (INVOS®, Covidien)

• Registration Number: NCT01531426
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.

Detailed Description

The measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, INVOS® (In-Vivo Optical Spectroscopy; Covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. If this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• over 18 years

Exclusion Criteria

• under 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIRS continuous monitoring	near infrared spectroscopy (INVOS®, Covidien)	-

Primary Outcome Measures

Name	Time	Method
neurological outcome (death; CPC: 5)	participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks	Cerebral Performance Category 5: death

Secondary Outcome Measures

Name	Time	Method
neurological outcome CPC 1-5	participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performed	CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death

Trial Locations

Locations (1)

Charité Universitätsmedizin; 🇩🇪 Berlin, Germany