## Protocol Section
### Identification Module
**NCT ID:** NCT06432881

**Brief Title:** Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

**Official Title:** Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

#### Organization Study ID Info
**ID:** GOOD0001
#### Organization
**Class:** INDUSTRY
**Full Name:** Masimo Corporation
### Status Module
#### Completion Date
**Date:** 2025-02-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02-21

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-05-22
### 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

### Description Module

**Brief Summary:** The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.

### Conditions Module

**Conditions:**

- Hypoxemia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 152

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects are enrolled into this arm and will have Sp02 measurements obtained.

**Intervention Names:**

- Device: RD SET Sensor

**Label:** RD SET Sensor

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- RD SET Sensor

**Description:** All subjects are enrolled into this arm and will have Sp02 measurements obtained.

**Name:** RD SET Sensor

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The study is designed to evaluate the performance of Masimo RD SET SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. SpO2 accuracy will be determined by calculating the ARMS value which will be reported as percent of oxygen saturated hemoglobin.

**Measure:** Investigation of skin pigmentation effect on performance of Masimo pulse oximetry

**Time Frame:** Approximately 30 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject is receiving care in an intensive care unit.
* Subject with an arterial catheter in place.
* Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air

Exclusion Criteria:

* Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity).
* Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
* Subjects with known allergic reactions to adhesive tapes.
* Subjects with arterial catheter placed in a lower extremity.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicalresearchdept@masimo.com

**Name:** Chelsea Frank

**Phone:** 949-297-7000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charleston

**Contacts:**

***Contact 1:***

- **Email:** clinicalresearchdept@masimo.com

- **Name:** Chelsea Frank

- **Phone:** 949-297-7000

- **Role:** CONTACT

**Country:** United States

**Facility:** Medical University of South Carolina

**State:** South Carolina

**Status:** RECRUITING

**Zip:** 29425

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Hypoxemia

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000860

- Term: Hypoxia

### Misc Info Module

- Version Holder: 2024-05-31
