Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

NCT ID: NCT06433934

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-11-30

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

Hypoxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxy2mask

Change oxymask to oxy2mask

Group Type: EXPERIMENTAL

Oxy2mask

Intervention Type: DEVICE

Open design oxygen mask

Interventions

Oxy2mask

Open design oxygen mask

Intervention Type: DEVICE

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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern Medicine

OTHER

Sponsor Role: lead

Responsible Party

Patti DeJuilio

Director Respiratory Care and Diagnostic Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan Carney

Role: STUDY_DIRECTOR

Northwestern Medicine IRB

Locations

Central DuPage Hospital

Winfield, Illinois, United States

Countries

United States

Central Contacts

Patti DeJuilio, MS

Role: CONTACT

patricia.dejuilio@nm.org

6309332432

Mary Henriksen, MS

Role: CONTACT

mary.henriksen@nm.org

6309335875

Other Identifiers

Oxymask

Identifier Type: -

Identifier Source: org_study_id