Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Device: GO2 PEEP MOUTHPIECE

• Registration Number: NCT04331366
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Study Start: 2020-04-08
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2021-02
• Results First Submitted: 2021-02-05
• Results First Submitted QC: 2021-02-05
• Results First Posted: 2021-02-10
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with GO2 PEEP MOUTHPIECE	GO2 PEEP MOUTHPIECE	Participants receiving treatment with the GO2 PEEP MOUTHPIECE

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation by Pulse Oximetry	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)	Pulse oximetry is a way to assess whether or not a patient needs help breathing. Oxygen saturation levels for healthy individuals are 95% and above.

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)	The number of breaths per minute was assessed before treatment, during treatment, and 15 minutes after the end of treatment.
Heart Rate	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)	Heart rate, in beats per minute, was assessed before treatment, during treatment, and 15 minutes after the end of treatment.
Blood Pressure	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)	Systolic and diastolic blood pressure was assessed before treatment, during treatment, and 15 minutes after the end of treatment.
Count of Participants With Subjective Work of Breathing	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)	Participants were observed for stridor, grunting, nasal flaring, or accessory muscle use. The presence of any of these indicates that increased effort is required for breathing.

Trial Locations

Locations (2)

Emory St. Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States