Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor

Completed · Not applicable

Conditions studied: Healthy

In brief

The purpose of this study was to conduct a side by side comparison of the accuracy of respiratory rate (RR) between our investigational Rainbow Acoustic Monitoring (RAM) small sensor and the FDA-cleared RAM Revision D sensor in healthy volunteers under controlled conditions.

Key facts

Study ID

NCT03122405

Run by

Masimo Corporation

People needed

29

Starts

2014-12-02

Expected to finish

2015-10-29

Last updated by the study team

2018-10-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female
• Physical status of ASA I or II
• Must be able to read and communicate in English
• Has signed written informed consent

You may not qualify if…

• ASA physical status of III, IV, and V
• Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participating in this study
• Inability to tolerate sitting still or minimal movement for at least 30 minutes

Where it is running

• Masimo Clinical Lab — Irvine, California, United States

Full record on ClinicalTrials.gov

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