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

NCT02841397 | Completed Results

• 1 other identifier: DORO0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

• Noninvasive Pulse Oximetry-determined SpHb Bias

  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.

  Duration of study participation is up to three days.

• Correlation of PVI Measurement Compared With PPV or SVV

  Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter

  Duration of study participation is up to three days.

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

  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).

  Duration of study participation is up to three days.

Study Arms (1)

Test group

EXPERIMENTAL

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

Device: Masimo Pulse CO-Oximeter

Interventions

Masimo Pulse CO-Oximeter DEVICE

Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted into the ICU
• Aged 18 years or older
• Mechanically ventilated
• Arterial line placed
• Vigileo/Flotrac System being used for guidance of fluid management

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Results Point of Contact

• Title: Cristina Johnson
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

(949) 297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 22, 2016
• Study Start: March 9, 2017
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: October 21, 2021
• Results First Posted: October 21, 2021

Record last verified: 2021-09

Locations

US (1)