An interventional study of Pulse CO-Oximeter sensor in Surgery and Anesthesia, sponsored by Masimo Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Masimo Corporation · Interventional and Other
This is a prospective, nonrandomized, sequential data collection study to evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including stroke volume variation (SVV) and/or pulse pressure variation (PPV).
Exclusion Criteria:
All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.
Device: Pulse CO-Oximeter sensor
Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.
Comparison of RPVi to SVV and/or PPV
To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.
Time frame: approximately 2-6 hours during surgery
| Milestone | Pulse Co-Oximeter Sensor |
|---|---|
| Started | 63 |
| Completed | 48 |
| Not completed | 15 |
| Withdrew: No a-line placed | 5 |
| Withdrew: Subject had gel nail polish | 1 |
| Withdrew: Nail length causing difficulties with sensor | 1 |
| Withdrew: Cancelled case | 6 |
| Withdrew: Physician decision | 2 |
To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.
No measurements were reported for this outcome.
Collected over 2-6 hours during surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulse Co-Oximeter Sensor | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Age, Customized(Participants) | Pulse Co-Oximeter Sensor |
|---|---|
| ≤ 18 years | 0 |
| Between 18 and 65 years | 23 |
| ≥ 65 years | 25 |
| Sex: Female, Male(Participants) | Pulse Co-Oximeter Sensor |
|---|---|
| Female | 15 |
| Male | 33 |
| Race/Ethnicity, Customized(Participants) | Pulse Co-Oximeter Sensor |
|---|---|
| American Indian or Alaskan Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 38 |
| Unknown or Not Reported | 5 |
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Plan to share: No
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Masimo Corporation