Status:
COMPLETED
Treating COVID-19 With a Bidirectional Oxygenation Valve
Lead Sponsor:
TMC HealthCare
Collaborating Sponsors:
PEEP Medical, LLC
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 preventin...
Eligibility Criteria
Inclusion
- Oxygen saturation \<93%
- Able to provide informed consent
- Not currently requiring intubation
- Receiving oxygen by face mask
Exclusion
- Unable or unwilling to provide informed consent, cognitive impairment
- Rapidly decompensating status requiring urgent or emergent higher level of care
Key Trial Info
Start Date :
March 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04326452
Start Date
March 27 2020
End Date
March 27 2021
Last Update
May 4 2022
Active Locations (3)
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1
TMC HealthCare
Tucson, Arizona, United States, 85712
2
Stanford University
Stanford, California, United States, 94305
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342