Correlation of Changes in PaO2 and ORi in Adult Patients

Masimo

Status: Completed

Conditions: Hyperoxia

Treatments: Device: ORi sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03488238

FLEM0007

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

ORi sensor

Experimental group

Description:

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

Treatment:

Device: ORi sensor