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:
Oslo University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01283529
First received: January 17, 2011
Last updated: July 20, 2011
Last verified: July 2011
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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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283529
Contacts
| Contact: Jo Eidet, MD | +47 23073700 | jo.eidet@ous-hf.no |
| Contact: Gunnar Bentsen, MD PhD | +47 23073700 | gunnar.bentsen@ous-hf.no |
Locations
| Norway | |
| Oslo University Hospital, Rikshospitalet | Recruiting |
| Oslo, Norway, 0871 | |
| Contact: Gunnar Bentsen, MD PhD +47 23073700 gbentsen@ous-hf.no | |
| Principal Investigator: Gunnar Bentsen, MD PhD | |
Sponsors and Collaborators
Oslo University Hospital
Investigators
| Principal Investigator: | Gunnar Bentsen, MD PhD | Oslo University Hospital |
More Information
No publications provided
| Responsible Party: | Gunnar Bentsen / Consultant, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01283529 History of Changes |
| Other Study ID Numbers: | 2010/27693, 2010/2576-4 |
| Study First Received: | January 17, 2011 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Norway: Regional commitee for medical for medical and health reserch etics Norway: Oslo University Hospital, Medical reserch department |
Keywords provided by Oslo University Hospital:
|
Intrathoracal blood volume Cardiac output Children |
ClinicalTrials.gov processed this record on May 16, 2013