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Cerebral Oxygenation in Cardiac Arrest and Hypothermia (CoCaHYp)

This study has been completed.
Medtronic - MITG
Information provided by (Responsible Party):
C. Storm, Charite University, Berlin, Germany Identifier:
First received: February 6, 2012
Last updated: February 22, 2013
Last verified: February 2013
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 Intervention
Cardiac Arrest
Device: near infrared spectroscopy (INVOS®, Covidien)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 94
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01531426

Charité Universitätsmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Medtronic - MITG
Principal Investigator: Christian Storm, MD Charite University, Berlin, Germany
  More Information

Responsible Party: C. Storm, Principal Investigator, Charite University, Berlin, Germany Identifier: NCT01531426     History of Changes
Other Study ID Numbers: CoCa-01-12
Study First Received: February 6, 2012
Last Updated: February 22, 2013

Keywords provided by Charite University, Berlin, Germany:

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms processed this record on April 26, 2017