INVSENSOR00013 Respiratory Rate Clinical Performance Study | NCT03440619

NCT03440619

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INVSENSOR00013 Test group	Experimental	All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.	Device: INVSENSOR00013

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INVSENSOR00013	Device	Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device	INVSENSOR00013 Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RRp Arms of Sensor Accuracy	Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.	1-5 hours

Eligibility Module

Name	Affiliation	Role
Ahmed Alghazi, M.D.	Masimo Corporation	Principal Investigator

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

IPD Sharing Statement Module

ID	Title	Description
FG000	INVSENSOR00013 Sensor	All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.

Baseline Characteristics Module

ID	Title	Description
BG000	INVSENSOR00013 Sensor	All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

RRp Arms of Sensor Accuracy

Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.

Posted

Number

respiration per minute (RPM)

1-5 hours

ID	Title	Description
OG000	INVSENSOR00013 Sensor	All subjects are enrolled into the test group and received one INVSENSOR00013 sensor.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	INVSENSOR00013 Sensor	All subjects are enrolled into the test group and received the INVSENSOR00013 sensor.