NCT05636098

Repeatability and Reproducibility of Oxygen Reserve Index (ORi)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the repeatability and reproducibility of ORi using an investigational Masimo rainbow sensor and FDA cleared rainbow sensors connected to the Masimo Radical-7 pulse oximeter and Masimo Root monitor in healthy volunteers as the subjects undergo a controlled hyperoxygenation protocol.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Masimo Rainbow Sensors	Noninvasive pulse oximeter sensor

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-01-11
• Completion: 2023-01-11
• First posted: 2022-12-05
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study