Treating COVID-19 With a Bidirectional Oxygenation Valve

May 2, 2022 updated by: TMC HealthCare

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • TMC HealthCare
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enrolled Subjects
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.
Device: bidirectional oxygenation mouthpiece
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse oximetry level
Time Frame: 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
Change from Baseline pulse oximetry level at 15 minutes post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate
Time Frame: Change from Baseline clinical measurements at 15 minutes post treatment
Change from Baseline clinical measurements at 15 minutes post treatment
Heart rate
Time Frame: Change from Baseline clinical measurements at 15 minutes post treatment
Change from Baseline clinical measurements at 15 minutes post treatment
Blood pressure
Time Frame: Change from Baseline clinical measurements at 15 minutes post treatment
Change from Baseline clinical measurements at 15 minutes post treatment
Systemic carbon dioxide
Time Frame: 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.
Change from Baseline clinical measurements at 15 minutes post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TMC HealthCare

Collaborators

PEEP Medical, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Actual)

March 27, 2021

Study Completion (Actual)

March 27, 2021

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID19PEEP2020
  • GO2 PEEP Study (Other Identifier: GO2 Devices)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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