Treating COVID-19 With a Bidirectional Oxygenation Valve
The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
2 other identifiers
interventional
10
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedStudy Start
First participant enrolled
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2021
CompletedMay 4, 2022
March 1, 2020
1 year
March 25, 2020
May 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pulse oximetry level
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
Change from Baseline pulse oximetry level at 15 minutes post treatment
Secondary Outcomes (4)
Respiratory rate
Change from Baseline clinical measurements at 15 minutes post treatment
Heart rate
Change from Baseline clinical measurements at 15 minutes post treatment
Blood pressure
Change from Baseline clinical measurements at 15 minutes post treatment
Systemic carbon dioxide
Change from Baseline clinical measurements at 15 minutes post treatment
Study Arms (1)
Enrolled Subjects
EXPERIMENTALThe 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.
Interventions
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.
Eligibility Criteria
You may qualify if:
- Oxygen saturation \<93%
- Able to provide informed consent
- Not currently requiring intubation
- Receiving oxygen by face mask
You may not qualify if:
- Unable or unwilling to provide informed consent, cognitive impairment
- Rapidly decompensating status requiring urgent or emergent higher level of care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TMC HealthCarelead
- PEEP Medical, LLCcollaborator
Study Sites (3)
TMC HealthCare
Tucson, Arizona, 85712, United States
Stanford University
Stanford, California, 94305, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 30, 2020
Study Start
March 27, 2020
Primary Completion
March 27, 2021
Study Completion
March 27, 2021
Last Updated
May 4, 2022
Record last verified: 2020-03