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Reference Values for Pulse Induced Continuous Cardiac Output (PiCCO) Variables in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283529
First Posted: January 26, 2011
Last Update Posted: August 30, 2016
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.
Information provided by (Responsible Party):
Gunnar Bentsen, Oslo University Hospital
January 17, 2011
January 26, 2011
August 30, 2016
January 2011
February 2014   (Final data collection date for primary outcome measure)
Reference values for PiCCO variables [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT01283529 on ClinicalTrials.gov Archive Site
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Reference Values for Pulse Induced Continuous Cardiac Output (PiCCO) Variables in Children
Reference Values for Cardiac Output and Blood Volume Variables in Children With Normal Cardiac Function Measured Under General Anesthesia.
Pulse induced continuous cardiac output (PiCCO) is an established technology for measurement of advanced hemodynamic variables in critically ill patients. PiCCO is approved and designed also for use in children, but there is a lack of documentation of reference values in children not suffering from a critical illness. The goal of this study is to establish such values.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
40 children age 0 - 15 years undergoing major neurosurgery under general anesthesia
Reference Values
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Children 0 - 15 years
Children undergoing neurosurgery in general anesthesia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2015
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age < 15 years
  • Scheduled for major neurosurgery in general anesthesia

Exclusion Criteria:

  • Cardiac disease
  • Infection / sepsis
Sexes Eligible for Study: All
up to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01283529
2010/27693
2010/2576-4 ( Other Identifier: Ethics commitee )
No
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Gunnar Bentsen, Oslo University Hospital
Oslo University Hospital
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Principal Investigator: Gunnar Bentsen, MD PhD Oslo University Hospital
Oslo University Hospital
August 2016