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To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | All subjects who meet the inclusion criteria and none of the exclusion criteria will be enrolled into the test group and will participate in data collection with use of the Nellcor™ Pulse Oximetry device with each of the market-released Nellcor™ Pulse Oximetry test sensors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pulse rate accuracy | Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the pulse rate measurement from the Nellcor Pulse Oximetry device to the heart rate measurements as obtained by ECG. | 2 - 3 hours |
| Evaluation of saturation accuracy | Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. | 2-3 Months |
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Inclusion Criteria:
Exclusion Criteria:
Participant is considered as being morbidly obese (defined as BMI >39.5).
Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized)
Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study.
Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
Participants with known respiratory conditions such as:
Participants with known heart or cardiovascular conditions such as:
Self-reported health conditions as identified in the Health Assessment Form:
Failure of the Allen's Test.
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Healthy participants ≥ 18 and < 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Clinical Physiology Lab | Denver | Colorado | 80218 | United States |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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