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

NCT ID: NCT02841397

Last Updated: 2021-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2017-10-11

Brief Summary

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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

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test group

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

Group Type EXPERIMENTAL

Masimo Pulse CO-Oximeter

Intervention Type DEVICE

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

Interventions

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Masimo Pulse CO-Oximeter

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DORO0001

Identifier Type: -

Identifier Source: org_study_id