Continuous Hemoglobin MeasurementNCT01364116
The Accuracy of Noninvasive and Continuous Hemoglobin Measurement by Pulse CO-Oximetry™ in Children Undergoing Volume Expansion
An observational study of Continuous Hemoglobin Measurement, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes noninvasive monitoring of venous hemoglobin level (SpHb). Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Continuous Hemoglobin Measurement
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to Dec 2011
- 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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 10 years old who were planned to take elective surgery which may cause patients' hemodynamic unstability. Patients who require intraoperative invasive arterial blood pressure monitoring.
Who may be able to join
None listed.
Who cannot join
- cardiopulmonary disease
- preoperative infection
- genetic disease
- hematologic disease
Trial locations and contacts
1 site in 1 country.
About this study
Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes noninvasive monitoring of venous hemoglobin level (SpHb).
The objective of this study
- to compare the simultaneous level of tHb and SpHb during operation and after volume expansion in children
- to assess the accuracy of amount of acute change of SpHb on Masimo and tHb
- Conditions
- Continuous Hemoglobin Measurement
- Keywords
- Pulse CO-Oximetry™, children, noninvasive
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin concentrations from laboratory lab and pulse Co-oximetry
volume expansion will be performed for 20 minuntes
Measured: before and after volume expansion (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startFeb 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Hemoglobin MeasurementStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364116
- Sponsor's protocol ID
- H-1012-127-346
- Status last verified
- Jun 2012
- First submitted
- 24 May 2011
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Noninvasive and Continuous Hemoglobin Measurement by Pulse CO-Oximetry™ in Children Undergoing Volume Expansion
- ClinicalTrials.gov ID
- NCT01364116
- Acronym / sponsor ID
- H-1012-127-346
- Conditions
- Continuous Hemoglobin Measurement
- Keywords
- Pulse CO-Oximetry™, children, noninvasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jun 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.
Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes noninvasive monitoring of venous hemoglobin level (SpHb).
The objective of this study
- to compare the simultaneous level of tHb and SpHb during operation and after volume expansion in children
- to assess the accuracy of amount of acute change of SpHb on Masimo and tHb
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 10 years old who were planned to take elective surgery which may cause patients' hemodynamic unstability. Patients who require intraoperative invasive arterial blood pressure monitoring.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- cardiopulmonary disease
- preoperative infection
- genetic disease
- hematologic disease
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
hemoglobin concentrations from laboratory lab and pulse Co-oximetry
Time frame: before and after volume expansion (20 minutes)
volume expansion will be performed for 20 minuntes
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 6 Jun 2012.
Related trials for Continuous Hemoglobin Measurement
RecruitingObservational study
Effect of Prone Position on Continuous Noninvasive Hemoglobin Measurement
Lumbar Stabilization Surgery, Noninvasive Hemoglobin Monitoring
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Continuous Hemoglobin Measurement, run by Seoul National University Hospital at 1 site in South Korea.
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 0 inclusion and 4 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 6 Jun 2012. 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 South Korea. 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?
hemoglobin concentrations from laboratory lab and pulse Co-oximetry (time frame: before and after volume expansion (20 minutes)). 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 6 Jun 2012.