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

COVID-19 Clinical Trial

— GO2 PEEP  

Official title:

GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331366
• Other study ID #: STUDY00000381
• Status: Completed
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• GO2 PEEP MOUTHPIECE
The GO2 PEEP MOUTHPIECE has a bidirectional valve that delivers PEEP with each breath. Participants will be provided a G02 PEEP MOUTHPIECE to use underneath the oxygen face mask and will be instructed to breathe slowly and deeply through the mouthpiece for 15 minutes total. Metrics for primary and secondary endpoints will be recorded immediately prior to use and then at 5, 10 and 15 minutes of use and then 15 minutes after cessation of use.

Locations

Country	Name	City	State
United States	Emory St. Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Saturation by Pulse Oximetry	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.	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Secondary	Respiratory Rate	The number of breaths per minute was assessed before treatment, during treatment, and 15 minutes after the end of treatment.	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Secondary	Heart Rate	Heart rate, in beats per minute, was assessed before treatment, during treatment, and 15 minutes after the end of treatment.	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Secondary	Blood Pressure	Systolic and diastolic blood pressure was assessed before treatment, during treatment, and 15 minutes after the end of treatment.	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Secondary	Count of Participants With Subjective Work of Breathing	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.	Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)