Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children
Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7
1 other identifier
interventional
81
1 country
1
Brief Summary
The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 26, 2014
March 1, 2014
4 months
September 19, 2012
March 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
one day
Secondary Outcomes (1)
influence of inhalation anesthetics
one day
Study Arms (2)
inhalation group
OTHER20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia
non-inhalational
OTHER40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.
Interventions
Eligibility Criteria
You may qualify if:
- children (\>= 3 kg until 8 years)
- ASA I-III
- written informed consent of legal representative
You may not qualify if:
- children \<= 3kg or \> 8 years
- emergency surgery
- allergy against sensor of SpHb(®)
- artery occlusive disease
- sepsis
- haemoglobinopathy
- specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Eva Wittenmeier
Mainz, 55131, Germany
Related Publications (1)
Wittenmeier E, Bellosevich S, Mauff S, Schmidtmann I, Eli M, Pestel G, Noppens RR. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study. Paediatr Anaesth. 2015 Oct;25(10):1046-53. doi: 10.1111/pan.12683. Epub 2015 Jul 14.
PMID: 26179143DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Wittenmeier
Johannes Gutenberg University Mainz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Eva Wittenmeier
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 26, 2012
Study Start
September 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
March 26, 2014
Record last verified: 2014-03