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

Reference Values Clinical Trial

Official title:

Reference Values for Cardiac Output and Blood Volume Variables in Children With Normal Cardiac Function Measured Under General Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283529
• Other study ID #: 2010/27693
• Secondary ID: 2010/2576-4
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: August 29, 2016
• Start date: January 2011
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional commitee for medical for medical and health reserch eticsNorway: Oslo University Hospital, Medical reserch department
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• Age < 15 years

• Scheduled for major neurosurgery in general anesthesia

Exclusion Criteria:

• Cardiac disease

• Infection / sepsis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Reference Values

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reference values for PiCCO variables		18 months	No