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

Masimo Corporation29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RAM sensorsDEVICE

Noninvasive acoustic monitoring device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Masimo Clinical Lab

Irvine, California, United States

Outcomes

Primary Outcomes

Performance comparison of RAM sensors by ARMS calculation

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.

Time frame: 50 minutes

Data from ClinicalTrials.gov

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