N/A N=31 Other

Correlation of Changes in PaO2 and ORi in Adult Patients

Hyperoxia

Bottom Line

View on ClinicalTrials.gov: NCT03488238 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 100 percentage of true positives

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ORi sensor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Masimo Corporation
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	100	—
PRIMARY Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	94.38	—
PRIMARY Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	95.05	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03488238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.