Correlation of Changes in PaO2 and ORi in Adult Patients

Completed

• Conditions: Hyperoxia
• Interventions: Device: ORi sensor

• Registration Number: NCT03488238
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-04
• Study Start: 2018-08-01
• Primary Completion: 2018-09-19
• Study Completion: 2018-09-19
• Disposition First Submitted: 2019-08-27
• Disposition First Submitted QC: 2019-08-27
• Status Verified: 2021-08
• Results First Submitted: 2021-08-23
• Results First Submitted QC: 2021-08-23
• Last Update Submitted: 2021-08-23
• Results First Posted: 2021-09-20
• Disposition First Posted: 2021-09-20
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	Less than 30 minutes	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.
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	Less than 30 mins	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.	Less than 30 mins	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.

Trial Locations

Locations (1)

UC Davis; 🇺🇸 Sacramento, California, United States