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Cerebral Oxygenation in Cardiac Arrest and Hypothermia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01531426
Acronym
CoCaHYp
Enrollment
94
Registered
2012-02-13
Start date
2012-01-31
Completion date
2013-01-31
Last updated
2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

resuscitation, hypothermia, outcome

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.

Interventions

DEVICEnear infrared spectroscopy (INVOS®, Covidien)

Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.

Sponsors

Medtronic - MITG
CollaboratorINDUSTRY
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* over 18 years

Exclusion criteria

* under 18 years

Design outcomes

Primary

MeasureTime frameDescription
neurological outcome (death; CPC: 5)participants will be followed for the duration of hospital stay, an expected average of 3-6 weeksCerebral Performance Category 5: death

Secondary

MeasureTime frameDescription
neurological outcome CPC 1-5participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performedCPC 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026