Clinical trial NCT04331366: Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19
Official title: GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Bidirectional oxygenation
Pulmonary compromise
Supplemental oxygen
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation Positive End Expiratory Pressure (PEEP) mouthpiece in coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen by non-rebreather mask.

Detailed description: Severe cases of COVID-19 often mimic the typical course of Adult Respiratory Distress Syndrome (ARDS) and its predictable sequelae. These patients often require intubation and ventilator support in order to sustain adequate oxygenation. Once a COVID-19 patient is intubated, Positive End Expiratory Pressure (PEEP) is a mainstay of treatment and is used in order to improve lung function, treat underlying atelectasis, improve oxygenation, and improve survival. In fact, early clinical data as well as reports from front line physicians treating COVID-19 suggest that PEEP has been the most effective treatment modality. In many cases, PEEP has resulted in improved oxygenation and improved survival.

PEEP decreases the propensity for the alveoli to collapse by increasing the air pressure in the lungs. This residual pressure in the lungs at the end of exhalation decreases shunting and allows for more complete gas exchange and improved oxygenation. In patients, PEEP is one of the safest ways to increase partial pressure of oxygen (PaO2) and is used on almost all modern ventilator settings.

The GO2 PEEP MOUTHPIECE is a simple, comfortable, and straightforward mouthpiece with a bidirectional valve that effectively delivers PEEP with every breath. Early application of the GO2 PEEP MOUTHPIECE in non-intubated COVID-19 patients may improve outcomes and save lives. Furthermore, this device may allow for less strain on limited resources, especially ventilators. This PEEP mouthpiece could be employed under an oxygen non-rebreather mask to improve oxygenation and avoid intubation.

Eligibility criteria: Inclusion Criteria:

* COVID-19 positive
* Oxygen saturation \<92%
* Able to provide informed consent
* Receiving oxygen by non-rebreather mask
* Not currently requiring intubation

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Cognitive impairment
* Rapidly decompensating status requiring urgent or emergent higher level of care

Primary outcomes:
measure: Oxygen Saturation by Pulse Oximetry
timeFrame: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Secondary outcomes:
measure: Respiratory Rate
timeFrame: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
measure: Heart Rate
timeFrame: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
measure: Blood Pressure
timeFrame: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
measure: Count of Participants With Subjective Work of Breathing
timeFrame: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Jeffrey Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: