An interventional study of In vivo SpHb and PVi Monitoring in Surgery, sponsored by Masimo Corporation. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Masimo Corporation (part of Danaher Corporation) · Interventional and Other
The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes for the surgical patient.
Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.
First submitted before Masimo Corporation became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinicians will be performing blood transfusions using hospital standard of care procedures.
Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.
Device: In vivo SpHb and PVi Monitoring
Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)
Average Volume of Allogenic RBC Transfused Intra-operatively
Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.
Time frame: Approximately 6-8 hours
| Milestone | Control Group | Evaluation Group |
|---|---|---|
| Started | 43 | 0 |
| Completed | 43 | 0 |
| Not completed | 0 | 0 |
Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Evaluation Group | — | — | — |
No participants enrolled in the evaluation group.
| Age, Categorical(Participants) | Control Group | Evaluation Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 0 | 29 |
| >=65 years | 14 | 0 | 14 |
| Sex: Female, Male(Participants) | Control Group | Evaluation Group | Total |
|---|---|---|---|
| Female | 22 | 0 | 22 |
| Male | 21 | 0 | 21 |
| Race/Ethnicity, Customized(Participants) | Control Group | Evaluation Group | Total |
|---|---|---|---|
| Black or African American | 9 | 0 | 9 |
| Hispanic, Latino, or Spanish origin | 2 | 0 | 2 |
| White or Caucasian | 32 | 0 | 32 |
| Region of Enrollment(participants) | Control Group | Evaluation Group | Total |
|---|---|---|---|
| United States | 43 | — | 43 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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