Trial Outcomes & Findings for SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor (NCT NCT03124602)
NCT ID: NCT03124602
Last Updated: 2019-08-22
Results Overview
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the ARMS Error value.
COMPLETED
NA
35 participants
1-5 hours per subject
2019-08-22
Participant Flow
Participant milestones
| Measure |
Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Baseline characteristics by cohort
| Measure |
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
n=25 Participants
All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-5 hours per subjectAccuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the ARMS Error value.
Outcome measures
| Measure |
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
n=25 Participants
All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
|
|---|---|
|
Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation
|
1.16 percent of oxygen saturated hemoglobin
|
Adverse Events
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Red Diamond Disposable Pulse Oximeter Sensor: Noninvasive Puls
n=35 participants at risk
All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
|
|---|---|
|
Injury, poisoning and procedural complications
Dizzy/Lightheaded, Vasovagal
|
8.6%
3/35 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place