NCT04326452

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: TMC HealthCare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	bidirectional oxygenation mouthpiece	Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.

Timeline

• Start date: 2020-03-27
• Primary completion: 2021-03-27
• Completion: 2021-03-27
• First posted: 2020-03-30
• Last updated: 2022-05-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study