Trial Outcomes & Findings for Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting (NCT NCT04490863)
NCT ID: NCT04490863
Last Updated: 2021-08-31
Results Overview
Coefficient of variation will be computed using Repeatability and Reproducibility variance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Approximately 90 minutes per subject
Results posted on
2021-08-31
Participant Flow
Participant milestones
| Measure |
Test Subjects
All subjects are enrolled and receive Rad-67 Pulse oximeter \& DCI Mini sensor for measurement of hemoglobin.
Rad-67 Pulse oximeter \& DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting
Baseline characteristics by cohort
| Measure |
Test Subjects
n=26 Participants
All subjects are enrolled and receive Rad-67 Pulse oximeter \& DCI Mini sensor for measurement of hemoglobin.
Rad-67 Pulse oximeter \& DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · More Than One Race
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Mexican
|
7 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Approximately 90 minutes per subjectCoefficient of variation will be computed using Repeatability and Reproducibility variance.
Outcome measures
| Measure |
Test Subjects
n=26 Participants
All subjects are enrolled and receive Rad-67 Pulse oximeter \& DCI Mini sensor for measurement of hemoglobin.
Rad-67 Pulse oximeter \& DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin
|
|---|---|
|
Coefficient of Variation of Rad-67
|
4.50 Coefficient of Variation percentage
|
Adverse Events
Test Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60