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

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: RAM sensors

Study type: Interventional

Funder types: Industry

Identifiers

NCT03122405

TR29836A-TP16846C

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Test group

Experimental group

Description:

The subjects will be enrolled in the test group and will simultaneously receive both RAM sensors.

Treatment:

Device: RAM sensors