Coronavirus InfectionNCT04326452
Treating COVID-19 With a Bidirectional Oxygenation Valve
A study testing bidirectional oxygenation mouthpiece in people with Coronavirus Infection, run by TMC HealthCare at 3 sites in United States.
Trial summary
This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- bidirectional oxygenation mouthpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Mar 2020to 27 Mar 2021
- 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
- Oxygen saturation <93%
- Able to provide informed consent
- Not currently requiring intubation
- Receiving oxygen by face mask
Who cannot join
- Unable or unwilling to provide informed consent, cognitive impairment
- Rapidly decompensating status requiring urgent or emergent higher level of care
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Stanford University
Stanford, California, 94305
TMC HealthCare
Tucson, Arizona, 85712
About this study
Official title: The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.
Read the detailed description
We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.
- Conditions
- Coronavirus Infection
- Being tested
- bidirectional oxygenation mouthpiece
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bidirectional oxygenation mouthpieceDevice
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects | Experimental | The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus. Receives: Device: bidirectional oxygenation mouthpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oximetry level
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
Measured: Change from Baseline pulse oximetry level at 15 minutes post treatment
Secondary outcomes (4)
Respiratory rate
Measured: Change from Baseline clinical measurements at 15 minutes post treatment
Heart rate
Measured: Change from Baseline clinical measurements at 15 minutes post treatment
Blood pressure
Measured: Change from Baseline clinical measurements at 15 minutes post treatment
Systemic carbon dioxide
Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.
Measured: Change from Baseline clinical measurements at 15 minutes post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start27 Mar 2020
- Primary completion27 Mar 2021
- Study completion27 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- TMC HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- PEEP Medical, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326452
- Sponsor's protocol ID
- COVID19PEEP2020
- Other IDs
- GO2 PEEP Study
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04326452
- Acronym / sponsor ID
- COVID19PEEP2020
- Conditions
- Coronavirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- TMC HealthCareUniversity, hospital or other
- Collaborators
- PEEP Medical, LLC
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 27 Mar 2021 (actual)
- First posted
- 30 Mar 2020 (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.
This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.
Detailed description
We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects | Experimental | Device: bidirectional oxygenation mouthpieceThe purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Oxygen saturation <93%
- Able to provide informed consent
- Not currently requiring intubation
- Receiving oxygen by face mask
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent, cognitive impairment
- Rapidly decompensating status requiring urgent or emergent higher level of care
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 |
|---|---|---|
| bidirectional oxygenation mouthpieceUse of our bidirectional oxygenation mouthpiece with conventional oxygen support. | Device | Enrolled Subjects |
Primary outcome
Pulse oximetry level
Time frame: Change from Baseline pulse oximetry level at 15 minutes post treatment
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
4 secondary outcomes
Respiratory rate
Time frame: Change from Baseline clinical measurements at 15 minutes post treatment
Heart rate
Time frame: Change from Baseline clinical measurements at 15 minutes post treatment
Blood pressure
Time frame: Change from Baseline clinical measurements at 15 minutes post treatment
Systemic carbon dioxide
Time frame: Change from Baseline clinical measurements at 15 minutes post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bidirectional oxygenation mouthpiece in people with Coronavirus Infection, run by TMC HealthCare at 3 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulse oximetry level (time frame: Change from Baseline pulse oximetry level at 15 minutes post treatment). 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 4 May 2022.