Back to resultsTreating COVID-19 With a Bidirectional Oxygenation Valve
Primary Purpose
Coronavirus Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bidirectional oxygenation mouthpiece
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Infection
Eligibility 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
Sites / Locations
- TMC HealthCare
- Stanford University
- Emory Saint Joseph's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enrolled Subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
Pulse oximetry level
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
Secondary Outcome Measures
Respiratory rate
Heart rate
Blood pressure
Systemic carbon dioxide
Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.
Full Information
NCT ID
NCT04326452
First Posted
March 25, 2020
Last Updated
May 2, 2022
Sponsor
TMC HealthCare
Collaborators
PEEP Medical, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04326452
Brief Title
Treating COVID-19 With a Bidirectional Oxygenation Valve
Official Title
The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
March 27, 2021 (Actual)
Study Completion Date
March 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TMC HealthCare
Collaborators
PEEP Medical, LLC
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enrolled Subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
bidirectional oxygenation mouthpiece
Intervention Description
Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.
Primary Outcome Measure Information:
Title
Pulse oximetry level
Description
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
Time Frame
Change from Baseline pulse oximetry level at 15 minutes post treatment
Secondary Outcome Measure Information:
Title
Respiratory rate
Time Frame
Change from Baseline clinical measurements at 15 minutes post treatment
Title
Heart rate
Time Frame
Change from Baseline clinical measurements at 15 minutes post treatment
Title
Blood pressure
Time Frame
Change from Baseline clinical measurements at 15 minutes post treatment
Title
Systemic carbon dioxide
Description
Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.
Time Frame
Change from Baseline clinical measurements at 15 minutes post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
TMC HealthCare
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treating COVID-19 With a Bidirectional Oxygenation Valve
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