## Protocol Section
### Identification Module
**NCT ID:** NCT06433934

**Brief Title:** Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

**Official Title:** Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

#### Organization Study ID Info
**ID:** Oxymask
#### Organization
**Class:** OTHER
**Full Name:** Northwestern Medicine
### Status Module
#### Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern Medicine

#### Responsible Party

**Investigator Affiliation:** Northwestern Medicine

**Investigator Full Name:** Patti DeJuilio

**Investigator Title:** Director Respiratory Care and Diagnostic Services

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask.

**Detailed Description:** Southmedic, Inc. has received approval to distribute a newly designed oxygen mask. The current design has been studied and the FiO2 delivered reported to be inconsistent. The purpose of this study is to determine if the performance is the same, better, or worse than current mask. We can evaluate performance by determining Liter flow required to maintain oxygen saturations that are within limits described in NM CDH oxygen protocol. We will measure the flow rate necessary to maintain the same saturation in adult patients using both the OxyMask and Oxy2Mask. The Oxymask has a flow device inside the mask that has been revised since implementation. The mask itself is otherwise unchanged. We intend to determine if the same amount of flow results in the same outcome.

This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same.

### Conditions Module

**Conditions:**

- Hypoxia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Each patient will receive mask #1, then receive mask #2. The flowrate to maintain same desired oxygen saturations will be documented.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Change oxymask to oxy2mask

**Intervention Names:**

- Device: Oxy2mask

**Label:** Oxy2mask

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Oxy2mask

**Description:** Open design oxygen mask

**Name:** Oxy2mask

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Flow (LPM) required to maintain target oxygen saturation

**Measure:** Required Flowrate

**Time Frame:** 4 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants have oxygen device and are being titrated per NM CDH oxygen protocol (maintained between 90%-96%; or 88% - 92% if CO2 retainer)
* Participants to have period of stability; 2 hours at same liter flow on open design mask, 5-15 lpm 02.
* All adult patients (\> 18 years old) in med surge units (bed tower)
* Post-op patients requiring oxygen on Post-op Day 2.
* Patients currently on \>5 LPM via nasal cannula, clinician can recommend the change to OxyMask. If remains on \>5 LPM via OxyMask, patient can be included.
* Oxygen protocol will be followed per standards of care.

Exclusion Criteria:

* Patients receiving home oxygen therapy who do not require additional oxygen during hospital stay.
* Patients with a history of Bleomycin therapy.
* Patients with a history of Paraquat poisoning
* Patients that are pregnant

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** patricia.dejuilio@nm.org

**Name:** Patti DeJuilio, MS

**Phone:** 6309332432

**Role:** CONTACT

**Contact 2:**

**Email:** mary.henriksen@nm.org

**Name:** Mary Henriksen, MS

**Phone:** 6309335875

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Winfield

**Country:** United States

**Facility:** Central DuPage Hospital

**State:** Illinois

**Zip:** 60190

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern Medicine IRB

**Name:** Megan Carney

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: Hypoxia

- 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
