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Correlation of Changes in PaO2 and ORi in Adult Patients

Primary Purpose

Hyperoxia

Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
ORi sensor
Sponsored by
Masimo Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ORi sensor

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2018
Last Updated
August 23, 2021
Sponsor
Masimo Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03488238
Brief Title
Correlation of Changes in PaO2 and ORi in Adult Patients
Official Title
Correlation of Changes in PaO2 and ORi in Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
September 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia

7. Study Design

Primary Purpose
Other
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORi sensor
Arm Type
Experimental
Arm Description
All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure
Intervention Type
Device
Intervention Name(s)
ORi sensor
Intervention Description
Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Primary Outcome Measure Information:
Title
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Description
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time Frame
Less than 30 mins
Title
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Description
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time Frame
Less than 30 mins
Title
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Description
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time Frame
Less than 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Correlation of Changes in PaO2 and ORi in Adult Patients

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