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CompletedNCT03122405Updated Oct 22, 2018

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

An interventional study of RAM sensors in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Masimo Corporation · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Oct 2015, 10 years 11 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Oct 2018.
  • Registered 2 years 4 months after the study started (first participant enrolled Dec 2014, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Masimo Corporation is the lead sponsor of 103 studies on the registry; 1 is open to participants now.

Of its 78 completed or terminated interventional studies of FDA-regulated products, 65 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Test group

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

    Device: RAM sensors

Interventions

  • DeviceRAM sensors

    Noninvasive acoustic monitoring device

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Masimo Clinical Lab
    Irvine, California 92618, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03122405
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Apr 20, 2017
Start date
Dec 2, 2014
Primary completion
Oct 29, 2015
Completion
Oct 29, 2015
Last update
Oct 22, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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