## Protocol Section
### Identification Module
**NCT ID:** NCT03124979

**Brief Title:** Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)

#### Organization Study ID Info
**ID:** TR22194-TP16113
#### Organization
**Class:** INDUSTRY
**Full Name:** Masimo Corporation
### Status Module
#### Completion Date
**Date:** 2012-04-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-07-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-04-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-07-28

**Type:** ACTUAL

**Results First Submit Date:** 2017-05-08

**Results First Submit QC Date:** 2017-06-28

#### Start Date
**Date:** 2012-01-18

**Type:** ACTUAL

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2017-04-24
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-14
**Study First Submit QC Date:** 2017-04-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Masimo Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 13

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

**Intervention Names:**

- Device: LNCS DBI Sensor

**Label:** Test Subject

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test Subject

**Description:** Noninvasive Measurement of SpO2

**Name:** LNCS DBI Sensor

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Accuracy of Sensor by Arms Calculation

**Time Frame:** 1-5 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Irvine

**Country:** United States

**Facility:** Masimo

**State:** California

**Zip:** 92618

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Test Subject

**Description:** All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

**ID:** EG000

**Other Num at Risk:** 13

**Serious Number At Risk:** 13

**Title:** Test Subject

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 13

**Units:** Participants

### Group

**ID:** BG000

**Title:** Test Subject

**Description:** All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

**Class Title:** 20-32 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** studies@masimo.com
**Organization:** Masimo
**Title:** Tala Harake
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.69
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 1-5 hours
**Title:** Accuracy of Sensor by Arms Calculation
**Type:** PRIMARY
**Type Units Analyzed:** data points
**Unit of Measure:** % of oxygen saturated hemoglobin
##### Group
**Description:** All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
**ID:** OG000
**Title:** Test Subject
### Participant Flow Module
#### Group
**Description:** All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
**ID:** FG000
**Title:** Test Subject
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True