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

This study is currently recruiting participants.

Verified July 2011 by Oslo University Hospital

Sponsor:

Information provided by:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01283529

First received: January 17, 2011

Last updated: July 20, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 17, 2011

Last Updated Date

July 20, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reference values for PiCCO variables [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01283529 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

40 children age 0 - 15 years undergoing major neurosurgery under general anesthesia

Condition ^ICMJE

Reference Values

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Children 0 - 15 years

Children undergoing neurosurgery in general anesthesia

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age < 15 years
Scheduled for major neurosurgery in general anesthesia

Exclusion Criteria:

Cardiac disease
Infection / sepsis

Gender

Both

Ages

up to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jo Eidet, MD	+47 23073700	jo.eidet@ous-hf.no
Contact: Gunnar Bentsen, MD PhD	+47 23073700	gunnar.bentsen@ous-hf.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01283529

Other Study ID Numbers ^ICMJE

2010/27693, 2010/2576-4

Has Data Monitoring Committee

Responsible Party

Gunnar Bentsen / Consultant, Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gunnar Bentsen, MD PhD

Oslo University Hospital

Information Provided By

Oslo University Hospital

Verification Date

July 2011

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

To Top