CompletedNot Applicable

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

United States50 participantsStarted 2017-03-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Noninvasive Pulse Oximetry-determined SpHb Bias

Timeframe: Duration of study participation is up to three days.

Correlation of PVI Measurement Compared With PPV or SVV

Timeframe: Duration of study participation is up to three days.

Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis

Timeframe: Duration of study participation is up to three days.

Trial details

NCT IDNCT02841397

SponsorMasimo Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-11

Results submitted2021-08-20

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