Correlation of Changes in PaO2 and ORi in Adult Patients

NCT03488238 | Completed Results

• 1 other identifier: FLEM0007
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxia

Outcome Measures

Primary Outcomes (3)

• 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.

  Less than 30 mins

• 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.

  Less than 30 mins

• 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.

  Less than 30 minutes

Study Arms (1)

ORi sensor

EXPERIMENTAL

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

Device: ORi sensor

Interventions

ORi sensor DEVICE

Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi

ORi sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years
• Adults unable to give primary consent
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cristina Johnson
• Organization: Masimo Corporation

clincalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 4, 2018
• Study Start: August 1, 2018
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: September 20, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-08

Locations

US (1)