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

Masimo Corporation1 site in 1 country29 target enrollmentDecember 2, 2014

ConditionsHealthy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 29
Locations: 1
Primary Endpoint: Performance comparison of RAM sensors by ARMS calculation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2, 2014

End Date

October 29, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Performance comparison of RAM sensors by ARMS calculation

Time Frame: 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.