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Treating COVID-19 With a Bidirectional Oxygenation Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326452
Recruitment Status : Completed
First Posted : March 30, 2020
Last Update Posted : May 4, 2022
Sponsor:
Collaborator:
PEEP Medical, LLC
Information provided by (Responsible Party):
TMC HealthCare

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Device: bidirectional oxygenation mouthpiece Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
Actual Study Start Date : March 27, 2020
Actual Primary Completion Date : March 27, 2021
Actual Study Completion Date : March 27, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Respiratory rate [ Time Frame: Change from Baseline clinical measurements at 15 minutes post treatment ]
  2. Heart rate [ Time Frame: Change from Baseline clinical measurements at 15 minutes post treatment ]
  3. Blood pressure [ Time Frame: Change from Baseline clinical measurements at 15 minutes post treatment ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326452


Locations
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United States, Arizona
TMC HealthCare
Tucson, Arizona, United States, 85712
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Georgia
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
TMC HealthCare
PEEP Medical, LLC
More Information
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Responsible Party: TMC HealthCare
ClinicalTrials.gov Identifier: NCT04326452    
Other Study ID Numbers: COVID19PEEP2020
GO2 PEEP Study ( Other Identifier: GO2 Devices )
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infections
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases