Performance Equivalence of Rainbow Acoustic Monitoring (R... | NCT03122405

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

NCT03122405

Sponsor

Masimo Corporation

Status

Completed

Last Update Posted

Oct 22, 2018Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

RAM sensors

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

Dec 2, 2014Actual

Primary Completion Date

Oct 29, 2015Actual

Completion Date

Oct 29, 2015Actual

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Apr 14, 2017

First Posted Date

Apr 20, 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 17, 2018

Last Update Posted Date

Oct 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	The subjects will be enrolled in the test group and will simultaneously receive both RAM sensors.	Device: RAM sensors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RAM sensors	Device	Noninvasive acoustic monitoring device	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

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