Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

NCT06433934 | Withdrawn FDA Device

• 1 other identifier: Oxymask
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Required Flowrate

  Flow (LPM) required to maintain target oxygen saturation

  4 hours

Study Arms (1)

Oxy2mask

EXPERIMENTAL

Change oxymask to oxy2mask

Device: Oxy2mask

Interventions

Oxy2mask DEVICE

Open design oxygen mask

Oxy2mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern Medicine: lead

Study Sites (1)

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Carney

  Northwestern Medicine IRB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 15, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)