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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03122405
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-02
• Primary Completion: 2015-10-29
• Study Completion: 2015-10-29
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-20
• Status Verified: 2018-10
• Disposition First Submitted: 2018-10-17
• Disposition First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Disposition First Posted: 2018-10-22
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance comparison of RAM sensors by ARMS calculation	50 minutes	Performance comparison was determined by comparing the noninvasive respiration rate measurement of the RAM sensors and calculating the arithmetic root mean square (Arms) error value.

Trial Locations

Locations (1)

Masimo Clinical Lab; 🇺🇸 Irvine, California, United States