Cerebral Oxygenation in Cardiac Arrest and Hypothermia (CoCaHYp)

February 22, 2013 updated by: C. Storm, Charite University, Berlin, Germany

Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients after cardiac arrest

Description

Inclusion Criteria:

  • over 18 years

Exclusion Criteria:

  • under 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Christian Storm, MD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 22, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoCa-01-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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