Working… Menu

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

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. Identifier: NCT01283529
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : August 30, 2016
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

Layout table for study information
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
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2015

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT01283529

Layout table for location information
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0871
Sponsors and Collaborators
Oslo University Hospital
Layout table for investigator information
Principal Investigator: Gunnar Bentsen, MD PhD Oslo University Hospital

Layout table for additonal information
Responsible Party: Gunnar Bentsen, Consultant, Oslo University Hospital 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