N/A
Completed N=50
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
Surgery
Source: ClinicalTrials.gov NCT02841397 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Noninvasive Pulse Oximetry-determined SpHb Bias — 0.9 g/dL
Summary
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Noninvasive Pulse Oximetry-determined SpHb Bias |
0.9 | — |
| PRIMARY Correlation of PVI Measurement Compared With PPV or SVV |
— | — |
| PRIMARY Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Admitted into the ICU
- Aged 18 years or older
- Mechanically ventilated
- Arterial line placed
- Vigileo/Flotrac System being used for guidance of fluid management
Exclusion Criteria
- Pregnancy
- Prisoner status
- Extreme hemodynamic instability
- Multiple vasopressors in use with questionable peripheral blood flow
- Lack of appropriate sites for sensor placement
- Patient or patient's legal representative refusal
Data sourced from ClinicalTrials.gov (NCT02841397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.