N/A N=50 Other

Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI

Surgery

Bottom Line

View on ClinicalTrials.gov: NCT02841397 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Noninvasive Pulse Oximetry-determined SpHb Bias — 0.9 g/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Masimo Pulse CO-Oximeter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Masimo Corporation
Primary completion: Oct 2017

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.