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

Masimo

Status: Completed

Conditions: Surgery

Treatments: Device: Masimo Pulse CO-Oximeter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02841397

DORO0001

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Test group

Experimental group

Description:

All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters.

Treatment:

Device: Masimo Pulse CO-Oximeter