An interventional study of INVSENSOR00006 in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Masimo Corporation · Interventional and Other
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. The subject will then be returned to inhaling room air.
Exclusion Criteria:
All subjects consented are enrolled into the test group and received the INVSENSOR00006.
Device: INVSENSOR00006
Noninvasive pulse oximeter sensor
Oxygen Saturation (SpO2) Accuracy of Sensor
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.
Time frame: 1-5 hours
| Milestone | INVSENSOR00006 |
|---|---|
| Started | 26 |
| Completed | 25 |
| Not completed | 1 |
| Withdrew: Unable to achieve minimum desaturation level | 1 |
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.
| % of oxygen saturated hemoglobin | INVSENSOR00006 |
|---|---|
| Oxygen Saturation (SpO2) Accuracy of Sensor | 1.16 |
Collected over 1 to 5 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INVSENSOR00006 | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Customized(Participants) | INVSENSOR00006 |
|---|---|
| <18 years | 0 |
| Between 18 to 50 years | 25 |
| >50 years | 0 |
| Sex: Female, Male(Participants) | INVSENSOR00006 |
|---|---|
| Female | 11 |
| Male | 14 |
| Race/Ethnicity, Customized(Participants) | INVSENSOR00006 |
|---|---|
| Asian or Pacific Islander | 3 |
| Caucasian | 10 |
| Black or African American | 6 |
| Hispanic | 5 |
| Native American | 1 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Masimo Corporation