Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Device: RAM sensors
- Registration Number
- NCT03122405
- Lead Sponsor
- Masimo Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test group RAM sensors The subjects will be enrolled in the test group and will simultaneously receive both RAM sensors.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Clinical Lab
🇺🇸Irvine, California, United States