Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
1 other identifier
interventional
447
1 country
7
Brief Summary
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
7 active sites
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, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedApril 8, 2019
April 1, 2019
1 month
October 10, 2016
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of hemoglobin measurement
Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
Up to 2 hours per subject
Study Arms (1)
Test subjects
EXPERIMENTALAll subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.
Interventions
Eligibility Criteria
You may qualify if:
- Age: Greater than one month
- Weight: Greater than or equal to 3kg
- The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
You may not qualify if:
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
- Subjects deemed not suitable for the study at the discretion of the investigator
- Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
- Decision-impaired adult and pediatric subjects who are unable to give consent and assent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Site 4
Burbank, California, United States
Site 5
Burbank, California, United States
Site 2
Irvine, California, United States
Site 7
Lake Forest, California, United States
Site 3
National City, California, United States
Site 6
Torrance, California, United States
Site 1
Charlotte, North Carolina, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2016
First Posted
October 12, 2016
Study Start
September 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
April 8, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share