Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI) | NCT03124979

NCT03124979

Protocol Section

Identification Module

Results Section

Participant Flow Module

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

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

Label	Type	Description	Intervention Names
Test Subject	Other	All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.	Device: LNCS DBI Sensor

Name	Type	Description	Arm Group Labels	Other Names
LNCS DBI Sensor	Device	Noninvasive Measurement of SpO2	Test Subject

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Sensor by Arms Calculation	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.	1-5 hours

Eligibility Module

Contacts/Locations Module

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

IPD Sharing Statement Module

ID	Title	Description
FG000	Test Subject	All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

Baseline Characteristics Module

ID	Title	Description
BG000	Test Subject	All subjects are enrolled into the test group and all subjects received the LNCS DBI 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, Customized			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

Accuracy of Sensor by Arms Calculation

Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Posted

Number

% of oxygen saturated hemoglobin

1-5 hours

data points

ID	Title	Description
OG000	Test Subject	All subjects are enrolled into the test group and all subjects received the LNCS DBI 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	Test Subject	All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

More Info Module

Certain Agreements