Trial Outcomes & Findings for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor (NCT NCT04584788)
NCT ID: NCT04584788
Last Updated: 2022-06-27
Results Overview
Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
1 visit up to 8 hours
Results posted on
2022-06-27
Participant Flow
Participant milestones
| Measure |
Healthy Adult Volunteers
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
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|---|---|
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Overall Study
STARTED
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37
|
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Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Healthy Adult Volunteers
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
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|---|---|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Adult Volunteers
n=25 Participants
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
|
|---|---|
|
Age, Customized
< 18 years of age
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0 Participants
n=25 Participants
|
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Age, Customized
18 to 45 years of age
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25 Participants
n=25 Participants
|
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Age, Customized
> 45 years of age
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 1 visit up to 8 hoursAccuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).
Outcome measures
| Measure |
Healthy Adult Volunteers
n=25 Participants
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
|
|---|---|
|
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
|
4.78 percentage of regional oxygen saturation
|
Adverse Events
Healthy Adult Volunteers
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Adult Volunteers
n=37 participants at risk
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
|
|---|---|
|
Injury, poisoning and procedural complications
Severe vasovagal reaction
|
2.7%
1/37 • 1 visit up to 8 hours
|
Other adverse events
| Measure |
Healthy Adult Volunteers
n=37 participants at risk
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
|
|---|---|
|
Injury, poisoning and procedural complications
Headache
|
8.1%
3/37 • 1 visit up to 8 hours
|
|
Injury, poisoning and procedural complications
Hematoma
|
2.7%
1/37 • 1 visit up to 8 hours
|
|
Injury, poisoning and procedural complications
Lightheadedness
|
16.2%
6/37 • 1 visit up to 8 hours
|
|
Injury, poisoning and procedural complications
Drop in blood pressure
|
10.8%
4/37 • 1 visit up to 8 hours
|
|
Injury, poisoning and procedural complications
Elevated heart rate
|
2.7%
1/37 • 1 visit up to 8 hours
|
|
Injury, poisoning and procedural complications
Unusual sensation near right kidney
|
2.7%
1/37 • 1 visit up to 8 hours
|
|
Injury, poisoning and procedural complications
Pressure near arterial line site
|
2.7%
1/37 • 1 visit up to 8 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place