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Cerebral Oxygenation in Cardiac Arrest and Hypothermia (CoCaHYp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01531426
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : February 25, 2013
Medtronic - MITG
Information provided by (Responsible Party):
C. Storm, 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.

Condition or disease Intervention/treatment
Cardiac Arrest Device: near infrared spectroscopy (INVOS®, Covidien)

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.

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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
NIRS continuous monitoring Device: near infrared spectroscopy (INVOS®, Covidien)
Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.
Other Names:
  • INVOS® (In-Vivo Optical Spectroscopy)
  • Covidien

Primary Outcome Measures :
  1. neurological outcome (death; CPC: 5) [ Time Frame: 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 :
  1. neurological outcome CPC 1-5 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after cardiac arrest

Inclusion Criteria:

  • over 18 years

Exclusion Criteria:

  • under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01531426

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Charité Universitätsmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Medtronic - MITG
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Principal Investigator: Christian Storm, MD Charite University, Berlin, Germany
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Responsible Party: C. Storm, Principal Investigator, Charite University, Berlin, Germany Identifier: NCT01531426    
Other Study ID Numbers: CoCa-01-12
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by C. Storm, Charite University, Berlin, Germany:
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes