Accuracy of Acoustic Rainbow Monitoring (ARM) Sensor | NCT03124862

Studies
Accuracy of Acoustic Rainbow Monitoring (ARM) Sensor

NCT03124862

Sponsor

Masimo Corporation

Status

Completed

Last Update Posted

Oct 24, 2018Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

ARM sensor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2009Actual

Primary Completion Date

May 22, 2012Actual

Completion Date

May 22, 2012Actual

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Oct 17, 2018

Certification/Extension First Submitted that Passed QC Review

Oct 17, 2018

Certification/Extension First Posted Date

Oct 22, 2018Actual

Last Update Submitted Date

Oct 22, 2018

Last Update Posted Date

Oct 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	The subjects will be enrolled into the test group and will receive ARM sensor.	Device: ARM sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARM sensor	Device	Acoustic Monitoring sensor that monitors respiratory rate	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Respiratory Rate determination	Accuracy is calculated using ARMS analysis	40 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy adult volunteers

Exclusion Criteria:

under age of 18

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Masimo Clinical Lab		Irvine	California	92618	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided