Trial Outcomes & Findings for Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry (NCT NCT04285411)
NCT ID: NCT04285411
Last Updated: 2020-06-02
Results Overview
This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate realized over the range throughout the hypoxia procedure. Testing was conducted under normal office environment conditions.
COMPLETED
NA
10 participants
90 Seconds
2020-06-02
Participant Flow
Following Institutional Review Board (IRB) approval Title: "Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry", Clinimark Study ID# PR 2019-353, eleven healthy adult volunteer subjects were screened and enrolled into the study. One subject was withdrawn due to poor device placement and time sync with the control oximeter.
Participant milestones
| Measure |
ARMS SpO2 70-100%
Comparison to Reference CO-Oximetry
Accuracy of the VitalDetect™ pulse oximetry system: The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
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|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Baseline characteristics by cohort
| Measure |
ARMS SpO2 70-100%
n=10 Participants
Comparison to Reference CO-Oximetry
Accuracy of the VitalDetect™ pulse oximetry system: The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
25.9 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
|
Skin tone
Light Skin Tone
|
4 Participants
n=99 Participants
|
|
Skin tone
Medium Light Skin tone
|
2 Participants
n=99 Participants
|
|
Skin tone
Medium Skin Tone
|
1 Participants
n=99 Participants
|
|
Skin tone
Dark Skin Tone
|
3 Participants
n=99 Participants
|
|
Weight
|
161.0 Lbs
STANDARD_DEVIATION 41.4 • n=99 Participants
|
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Height
|
68.4 inches
STANDARD_DEVIATION 4.2 • n=99 Participants
|
|
Body Mass Index (BMI)
|
24.0 kg/m^2
STANDARD_DEVIATION 5.1 • n=99 Participants
|
PRIMARY outcome
Timeframe: 90 SecondsPopulation: Five (5) males, five (5) females (age: 19-38yrs, weight: 105-228 lbs, height: 63-75", BMI: 18.0-34.7). Race ethnicity, two (2) Black / African-Americans, one (1) Asian, seven (7) White. Nine (9) Non-Hispanic / Non-Latino, one (1) of Hispanic /Latino. Skin pigmentation ranged from light to dark meeting the requirement of at least 2 darkly pigmented
This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate realized over the range throughout the hypoxia procedure. Testing was conducted under normal office environment conditions.
Outcome measures
| Measure |
ARMS SpO2 70-100%
n=10 Participants
Comparison to Reference CO-Oximetry
|
|---|---|
|
Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry.
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3.1 percent
Standard Deviation 0.6
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SECONDARY outcome
Timeframe: 90 SecondsPopulation: Five (5) males, five (5) females (age: 19-38yrs, weight: 105-228 lbs, height: 63-75", BMI: 18.0-34.7). Race / ethnicity, two (2) Black / African-Americans, one (1) Asian, seven (7) White. Nine (9) Non-Hispanic / Non-Latino, one (1) Hispanic /Latino. Skin pigmentation / tones met requirement of at least 2 darkly pigmented or 15 % of the subject pool
The pulse rate accuracy was compared to ECG Heart Rate as recorded by the S5 Multi-parameter monitor. Passing criteria was an ARMS of 3 bpm or better based measurements observed during the pulse oximetry evaluation.
Outcome measures
| Measure |
ARMS SpO2 70-100%
n=10 Participants
Comparison to Reference CO-Oximetry
|
|---|---|
|
The Pulse Rate Accuracy Compared to ECG Heart Rate.
|
2.7 percent
Standard Deviation 06
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Adverse Events
ARMS SpO2 70-100%
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: LTE60