NCT03122405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

April 14, 2017

Last Update Submit

October 17, 2018

Conditions

Healthy

Outcome Measures

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.

    50 minutes

Study Arms (1)

Test group

EXPERIMENTAL

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

Device: RAM sensors

Interventions

RAM sensorsDEVICE

Noninvasive acoustic monitoring device

Test group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Physical status of ASA I or II
  • Must be able to read and communicate in English
  • Has signed written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 20, 2017

Study Start

December 2, 2014

Primary Completion

October 29, 2015

Study Completion

October 29, 2015

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

US(1)