HypoxiaNCT06433934
Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
A study testing Oxy2mask in people with Hypoxia, run by Northwestern Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- Oxy2mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Oxy2mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxy2maskDevice
Open design oxygen mask
| Study group | Role | What they receive |
|---|---|---|
| Oxy2mask | Experimental | Change oxymask to oxy2mask Receives: Device: Oxy2mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Required Flowrate
Flow (LPM) required to maintain target oxygen saturation
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start30 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: The PI is no longer with the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will receive mask #1, then receive mask #2. The flowrate to maintain same desired oxygen saturations will be documented.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Carney, Study director, Northwestern Medicine IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433934
- Sponsor's protocol ID
- Oxymask
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
- ClinicalTrials.gov ID
- NCT06433934
- Acronym / sponsor ID
- Oxymask
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is no longer with the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern MedicineUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will receive mask #1, then receive mask #2. The flowrate to maintain same desired oxygen saturations will be documented.
| Arm | Type | Receives |
|---|---|---|
| Oxy2mask | Experimental | Device: Oxy2maskChange oxymask to oxy2mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxy2maskOpen design oxygen mask | Device | Oxy2mask |
Primary outcome
Required Flowrate
Time frame: 4 hours
Flow (LPM) required to maintain target oxygen saturation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Carney study director
Northwestern Medicine IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxy2mask in people with Hypoxia, run by Northwestern Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Required Flowrate (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.