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

This study is currently recruiting participants.
Verified January 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Gunnar Bentsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01283529
First received: January 17, 2011
Last updated: January 13, 2014
Last verified: January 2014

January 17, 2011
January 13, 2014
January 2011
February 2014   (final data collection date for primary outcome measure)
Reference values for PiCCO variables [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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.
 
Recruiting
40
February 2014
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
Both
up to 15 Years
No
Contact: Jo Eidet, MD +47 23073700 jo.eidet@ous-hf.no
Contact: Gunnar Bentsen, MD PhD +47 23073700 gunnar.bentsen@ous-hf.no
Norway
 
NCT01283529
2010/27693, 2010/2576-4
No
Gunnar Bentsen, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Gunnar Bentsen, MD PhD Oslo University Hospital
Oslo University Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP