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OpenTrials
Completed

NCT Number: NCT03122405

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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Clinical Lab

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAM sensors

Device

Noninvasive acoustic monitoring device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2017
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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