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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gunnar Bentsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01283529
First received: January 17, 2011
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
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
Reference Values

Study Type: Observational
Study Design: 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.

Further study details as provided by Oslo University Hospital:

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

Enrollment: 31
Study Start Date: January 2011
Study Completion Date: September 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children 0 - 15 years
Children undergoing neurosurgery in general anesthesia

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 )
Study First Received: January 17, 2011
Last Updated: August 29, 2016

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

ClinicalTrials.gov processed this record on April 27, 2017