Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

Hypoxia Clinical Trial

Official title:

Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433934
• Other study ID #: Oxymask
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Northwestern Medicine
• Contact: Patti DeJuilio, MS
• Phone: 6309332432
• Email: patricia.dejuilio[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• Oxy2mask
Open design oxygen mask

Locations

Country	Name	City	State
United States	Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Required Flowrate	Flow (LPM) required to maintain target oxygen saturation	4 hours