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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03122405

Enrollment

Registered

2017-04-20

Start date

2014-12-02

Completion date

2015-10-29

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DEVICERAM sensors

Noninvasive acoustic monitoring device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026