Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00006 (NCT NCT03435211)
NCT ID: NCT03435211
Last Updated: 2024-09-19
Results Overview
Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value.
COMPLETED
52 participants
1-5 hours
2024-09-19
Participant Flow
Of the 52 enrolled participants, 26 met inclusion criteria and proceeded to the study. The remainder of the enrolled participants include screen failures and subjects that did not proceed due to time constraints.
Participant milestones
| Measure |
INVSENSOR00006
All subjects consented are enrolled into the test group and received the INVSENSOR00006.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
INVSENSOR00006
All subjects consented are enrolled into the test group and received the INVSENSOR00006.
|
|---|---|
|
Overall Study
Unable to achieve minimum desaturation level
|
1
|
Baseline Characteristics
Desaturation Validation of INVSENSOR00006
Baseline characteristics by cohort
| Measure |
INVSENSOR00006
n=25 Participants
All subjects consented are enrolled into the test group and received the INVSENSOR00006.
|
|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
Between 18 to 50 years
|
25 Participants
n=99 Participants
|
|
Age, Customized
>50 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-5 hoursPerformance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value.
Outcome measures
| Measure |
INVSENSOR00006
n=978 blood samples
All subjects consented are enrolled into the test group and received the INVSENSOR00006.
|
|---|---|
|
Oxygen Saturation (SpO2) Accuracy of Sensor
|
1.16 % of oxygen saturated hemoglobin
|
Adverse Events
INVSENSOR00006
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