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

August 29, 2016 updated by: Gunnar Bentsen, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0871
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac disease
  • Infection / sepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reference values for PiCCO variables
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Gunnar Bentsen, MD PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 17, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimate)

January 26, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/27693
  • 2010/2576-4 (Other Identifier: Ethics commitee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reference Values

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe