## Protocol Section
### Identification Module
**NCT ID:** NCT03897179

**Brief Title:** INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

**Official Title:** INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

#### Organization Study ID Info
**ID:** TP-19608
#### Organization
**Class:** INDUSTRY
**Full Name:** Masimo Corporation
### Status Module
#### Completion Date
**Date:** 2019-02-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-27

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-02-25

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-03-27

**Type:** ACTUAL

**Results First Submit Date:** 2020-03-13

**Results First Submit QC Date:** 2020-03-13

#### Start Date
**Date:** 2019-02-13

**Type:** ACTUAL

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2019-04-01
**Type:** ACTUAL
**Study First Submit Date:** 2019-03-20
**Study First Submit QC Date:** 2019-03-28
### 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

### Description Module

**Brief Summary:** This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 27

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

**Intervention Names:**

- Device: INVSENSOR00032 and INVSENSOR00033

**Label:** INVSENSOR00032 and INVSENSOR00033 test group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- INVSENSOR00032 and INVSENSOR00033 test group

**Description:** Investigational pulse oximeter device

**Name:** INVSENSOR00032 and INVSENSOR00033

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 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 INVSENSOR00032 and/or INVSENSOR00033 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.

**Measure:** RRp Arms of Sensor Accuracy

**Time Frame:** 1-5 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential.

Exclusion Criteria:

* Physical status of ASA III, IV, or V
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Subjects wearing acrylic nails or subjects refusing to remove nail polish
* Subjects who have a nail deformity on the measurement finger
* Subjects who do not have adequate skin integrity on the measurement finger
* Excluded at the Principal Investigator's discretion

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Irvine

**Country:** United States

**Facility:** Masimo Corporation

**State:** California

**Zip:** 92618

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-12-18

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 10638711

- Type Abbrev: Prot_SAP

- Upload Date: 2020-03-13T18:20

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** INVSENSOR00032 and INVSENSOR00033 Test Group

**Deaths Num At Risk:** 27

**Description:** All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device

**ID:** EG000

**Other Num at Risk:** 27

**Serious Number At Risk:** 27

**Title:** INVSENSOR00032 and INVSENSOR00033 Test Group

**Frequency Threshold:** 0

**Time Frame:** Adverse event data was collected over the course of the study (13 days).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 27

**Units:** Participants

### Group

**ID:** BG000

**Title:** INVSENSOR00032 and INVSENSOR00033 Test Group

**Description:** All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 26

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 14

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Class Title:** African American

#### Measurement

**Group ID:** BG000

**Value:** 4

**Class Title:** Asian or Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 9

**Class Title:** Hispanic

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 27

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** studies@masimo.com
**Organization:** Masimo
**Phone:** 949-297-7000
**Title:** Ahmed Alghazi
## 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:** 2.1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 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 INVSENSOR00032 and/or INVSENSOR00033 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.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 1-5 hours
**Title:** RRp Arms of Sensor Accuracy
**Type:** PRIMARY
**Unit of Measure:** respiration per minute (RPM)
##### Group
**Description:** All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device
**ID:** OG000
**Title:** INVSENSOR00032 and INVSENSOR00033 Test Group
### Participant Flow Module
#### Group
**Description:** All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.

INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device
**ID:** FG000
**Title:** INVSENSOR00032 and INVSENSOR00033 Test Group
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 27
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 26
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Has Results:** True