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

Completed

• Conditions: Surgery
• Interventions: Device: Masimo Pulse CO-Oximeter

• Registration Number: NCT02841397
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Study Start: 2017-03-09
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Disposition First Submitted: 2018-10-09
• Results First Submitted: 2021-08-20
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-23
• Disposition First Submitted QC: 2021-09-23
• Last Update Submitted: 2021-09-23
• Results First Posted: 2021-10-21
• Disposition First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis	Duration of study participation is up to three days.	Concordance will be determined by comparing the trending ability of the Oxygen Reserve Index (ORI) measurement of the sensor with that of Partial Pressure of Oxygen in Blood (PaO2).
Noninvasive Pulse Oximetry-determined SpHb Bias	Duration of study participation is up to three days.	Accuracy of SpHb will be determined by comparing it to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from SpHb value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Correlation of PVI Measurement Compared With PPV or SVV	Duration of study participation is up to three days.	Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States