Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02247765 | Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion | PHASE3 | COMPLETED | 18 | — | — | Nov 1, 2014 | Dec 1, 2014 | May 5, 2017 | 2 | United States |
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
| Arm | Type | Description |
|---|---|---|
| Arterial Line | EXPERIMENTAL | CO-Oximetry value obtained as a comparator. Obtained during motion conditions. |
| Motion | EXPERIMENTAL | The subject has to perform motions during the procedure. This is to verify that device is able to read through motion. |
| Name | Type | Description |
|---|---|---|
| Arterial line | DEVICE | Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601 |
| Motion | DEVICE | The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure. |
Inclusion Criteria: * Male or female of any race * 18-50 years old, inclusive * Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) * Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced prac...