Reference ValuesNCT01283529
Reference Values for Pulse Induced Continuous Cardiac Output (PiCCO) Variables in Children
An observational study of Reference Values, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Reference Values
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 40 children age 0 - 15 years undergoing major neurosurgery under general anesthesia
Who may be able to join
- Age < 15 years
- Scheduled for major neurosurgery in general anesthesia
Who cannot join
- Cardiac disease
- Infection / sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Reference Values
- Keywords
- Intrathoracal blood volume, Cardiac output, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children 0 - 15 years | Children undergoing neurosurgery in general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference values for PiCCO variables
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reference ValuesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Bentsen, Oslo University Hospital
- Investigators
- Gunnar Bentsen, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283529
- Sponsor's protocol ID
- 2010/27693
- Other IDs
- 2010/2576-4
- Status last verified
- Aug 2016
- First submitted
- 17 Jan 2011
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for Cardiac Output and Blood Volume Variables in Children With Normal Cardiac Function Measured Under General Anesthesia.
- ClinicalTrials.gov ID
- NCT01283529
- Acronym / sponsor ID
- 2010/27693
- Conditions
- Reference Values
- Keywords
- Intrathoracal blood volume, Cardiac output, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children 0 - 15 years | – | –Children undergoing neurosurgery in general anesthesia |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 40 children age 0 - 15 years undergoing major neurosurgery under general anesthesia
Key inclusion criteria (2 listed)
- Age < 15 years
- Scheduled for major neurosurgery in general anesthesia
Key exclusion criteria (2 listed)
- Cardiac disease
- Infection / sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference values for PiCCO variables
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
Related trials for Reference Values
RecruitingObservational study
Normal Values in Hearing and Balance Testing
Healthy Volunteer
Recruiting
Tyrannosaurus Flex: Finding the "Fair-ly Normal" Grip
Grip Strength, Hand Strength
RecruitingObservational study
A Study on Gastrointestinal Transit Time at the Population Level
Gastrointestinal Transit Time
RecruitingObservational study
Multimodal Cardiovascular and Hepatic Population Imaging
Healthy Volunteers, Imaging Evaluation
Not yet recruitingObservational study
Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
Pediatric, Coagulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Bentsen, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reference Values, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference values for PiCCO variables (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.