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
About this trial
This is an interventional other trial for Hyperoxia
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
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
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
Learn more about this trial
Correlation of Changes in PaO2 and ORi in Adult Patients
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