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

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ClinicalTrials.gov Identifier: NCT01283529
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Gunnar Bentsen, Oslo University Hospital

Brief Summary:
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.

Condition or disease
Reference Values

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reference Values for Cardiac Output and Blood Volume Variables in Children With Normal Cardiac Function Measured Under General Anesthesia.
Study Start Date : January 2011
Primary Completion Date : February 2014
Study Completion Date : September 2015

Group/Cohort
Children 0 - 15 years
Children undergoing neurosurgery in general anesthesia



Primary Outcome Measures :
  1. Reference values for PiCCO variables [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 children age 0 - 15 years undergoing major neurosurgery under general anesthesia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac disease
  • Infection / sepsis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283529


Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0871
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Gunnar Bentsen, MD PhD Oslo University Hospital

Responsible Party: Gunnar Bentsen, Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01283529     History of Changes
Other Study ID Numbers: 2010/27693
2010/2576-4 ( Other Identifier: Ethics commitee )
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Gunnar Bentsen, Oslo University Hospital:
Intrathoracal blood volume
Cardiac output
Children