Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting
Study Details
Study Description
Brief Summary
The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective blood donors at a donation center.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test subjects All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin. |
Device: Rad-67 Pulse oximeter & DCI Mini sensor
Noninvasive pulse oximeter that measures hemoglobin
|
Outcome Measures
Primary Outcome Measures
- Coefficient of Variation of Rad-67 [Approximately 90 minutes per subject]
Coefficient of variation will be computed using Repeatability and Reproducibility variance.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 18 years of age
-
Weight at least 110 pounds
-
Subjects with the intention of being screened for eligibility to donate blood
-
The subject has given written informed consent to participate in the study
Exclusion Criteria:
-
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, infections, abnormalities, etc.
-
Subjects unwilling to remove nail polish or acrylic nails
-
Subjects with blood cancers such as leukemia
-
Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
-
Subjects with self-disclosed/known pregnancy at the time of enrollment
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Blood Bank - Site 1 | San Diego | California | United States | 92102 |
Sponsors and Collaborators
- Masimo Corporation
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- SDBB0005
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Test Subjects |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 26 |
| COMPLETED | 26 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Test Subjects |
|---|---|
| Arm/Group Description | 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 Participants | 26 |
| Age (Count of Participants) | |
| <=18 years |
1
3.8%
|
| Between 18 and 65 years |
23
88.5%
|
| >=65 years |
2
7.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
15
57.7%
|
| Male |
11
42.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian |
2
7.7%
|
| Native Hawaiian or Other Pacific Islander |
1
3.8%
|
| Black or African American |
1
3.8%
|
| White |
12
46.2%
|
| More Than One Race |
1
3.8%
|
| Unknown or Not Reported |
1
3.8%
|
| Mexican |
7
26.9%
|
| Middle Eastern |
1
3.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
26
100%
|
Outcome Measures
| Title | Coefficient of Variation of Rad-67 |
|---|---|
| Description | Coefficient of variation will be computed using Repeatability and Reproducibility variance. |
| Time Frame | Approximately 90 minutes per subject |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Test Subjects |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 26 |
| Number [Coefficient of Variation percentage] |
4.50
|
Adverse Events
| Time Frame | Approximately 90 minutes per subject | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Test Subjects | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Test Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | |
Serious Adverse Events |
||
| Test Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Test Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Vikram Ramakanth |
|---|---|
| Organization | Masimo Corporation |
| Phone | 949-297-7000 |
| ClinicalResearchDept@masimo.com |
- SDBB0005