Treating COVID-19 With a Bidirectional Oxygenation Valve

Not Applicable

Completed

• Conditions: Coronavirus Infection
• Interventions: Device: bidirectional oxygenation mouthpiece

• Registration Number: NCT04326452
• Lead Sponsor: TMC HealthCare

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.

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 Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-25
• Study Start: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Primary Completion: 2021-03-27
• Study Completion: 2021-03-27
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Oxygen saturation <93%
• Able to provide informed consent
• Not currently requiring intubation
• Receiving oxygen by face mask

Exclusion Criteria

• Unable or unwilling to provide informed consent, cognitive impairment
• Rapidly decompensating status requiring urgent or emergent higher level of care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enrolled Subjects	bidirectional oxygenation mouthpiece	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.

Primary Outcome Measures

Name	Time	Method
Pulse oximetry level	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

Secondary Outcome Measures

Name	Time	Method
Systemic carbon dioxide	Change from Baseline clinical measurements at 15 minutes post treatment	Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.
Respiratory rate	Change from Baseline clinical measurements at 15 minutes post treatment
Blood pressure	Change from Baseline clinical measurements at 15 minutes post treatment
Heart rate	Change from Baseline clinical measurements at 15 minutes post treatment

Trial Locations

Locations (3)

TMC HealthCare; 🇺🇸 Tucson, Arizona, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Stanford University; 🇺🇸 Stanford, California, United States