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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.
TMC HealthCare
Tucson, Arizona, United States
Stanford University
Stanford, California, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Pulse oximetry level
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
Time frame: Change from Baseline pulse oximetry level at 15 minutes post treatment
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
Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.
Time frame: Change from Baseline clinical measurements at 15 minutes post treatment
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