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Cerebral Oxygenation in Cardiac Arrest and Hypothermia (CoCaHYp)

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
C. Storm, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01531426
First received: February 6, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients after cardiac arrest

Criteria

Inclusion Criteria:

  • over 18 years

Exclusion Criteria:

  • under 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531426

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

No publications provided

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

Keywords provided by Charite University, Berlin, Germany:
resuscitation
hypothermia
outcome

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013