Correlation of Changes in PaO2 and ORi in Adult Patients

NCT ID: NCT03488238

Last Updated: 2021-09-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-09-19

Brief Summary

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The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.

Detailed Description

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Conditions

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Hyperoxia

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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ORi sensor

All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure

Group Type EXPERIMENTAL

ORi sensor

Intervention Type DEVICE

Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi

Interventions

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ORi sensor

Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age greater than 18 years
* ASA physical status III or IV
* Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia

Exclusion Criteria

* Age less than 18 years
* Adults unable to give primary consent
* Pregnancy
* Prisoners
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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UC Davis

Sacramento, 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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FLEM0007

Identifier Type: -

Identifier Source: org_study_id

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