NCT02841397

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

Validation of a Pulse Oximetry Based Hemoglobin Measurement System. Comparison of Plethysmographic Variability Index to Standard Methods of Guiding Fluid and Transfusion Management in the Critically Ill Adult Patients. Validation of Clinical Efficacy of ORI for Supplemental Oxygen Titration

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery

Interventions

Type	Name	Description
DEVICE	Masimo Pulse CO-Oximeter	Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index

Timeline

• Start date: 2017-03-09
• Primary completion: 2017-10-11
• Completion: 2017-10-11
• First posted: 2016-07-22
• Last updated: 2021-10-21
• Results posted: 2021-10-21

Locations

1 site across 1 country: United States