Treating COVID-19 With a Bidirectional Oxygenation Valve

Coronavirus Infection Clinical Trial

Official title:

The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326452
• Other study ID #: COVID19PEEP2020
• Secondary ID: GO2 PEEP Study
• Status: Completed
• Phase: N/A
• Start date: March 27, 2020
• Est. completion date: March 27, 2021

Study information

• Verified date: March 2020
• Source: TMC HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 27, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Infections

Intervention

Device:
• bidirectional oxygenation mouthpiece
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Stanford University	Stanford	California
United States	TMC HealthCare	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
TMC HealthCare	PEEP Medical, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory rate		Change from Baseline clinical measurements at 15 minutes post treatment
Secondary	Heart rate		Change from Baseline clinical measurements at 15 minutes post treatment
Secondary	Blood pressure		Change from Baseline clinical measurements at 15 minutes post treatment
Secondary	Systemic carbon dioxide	Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.	Change from Baseline clinical measurements at 15 minutes post treatment