NCT03124862

Brief Summary

The purpose of the study was to conduct a side by side comparison of the accuracy of the respiratory rate (RR) between our Acoustic Rainbow Monitoring (ARM) sensor and the Oridian Microcap Capnograph in healthy adults. Our hypothesis was that the ARM sensor would have comparable or a better performance than the capnograph.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable healthy

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

March 17, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2012

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

April 14, 2017

Last Update Submit

October 22, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Respiratory Rate determination

    Accuracy is calculated using ARMS analysis

    40 minutes

Study Arms (1)

Test group

EXPERIMENTAL

The subjects will be enrolled into the test group and will receive ARM sensor.

Device: ARM sensor

Interventions

ARM sensorDEVICE

Acoustic Monitoring sensor that monitors respiratory rate

Also known as: RAS-125c
Test group

Eligibility Criteria

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

You may qualify if:

  • healthy adult volunteers

You may not qualify if:

  • under age of 18

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 24, 2017

Study Start

March 17, 2009

Primary Completion

May 22, 2012

Study Completion

May 22, 2012

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)