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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04331366

Acronym

GO2 PEEP

Enrollment

Registered

2020-04-02

Start date

2020-04-08

Completion date

2020-08-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Bidirectional oxygenation, Pulmonary compromise, Supplemental oxygen

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.

Interventions

DEVICEGO2 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled at Emory Saint Joseph's Hospital and Emory University Hospital in Atlanta, Georgia. Enrollment began on April 8, 2020 and all follow up was complete by August 31, 2020.

Participants by arm

Arm	Count
GO2 PEEP MOUTHPIECE Participants receiving treatment with the GO2 PEEP MOUTHPIECE.	2
Total	2

Baseline characteristics

Characteristic	GO2 PEEP MOUTHPIECE
Age, Continuous	60.71 years STANDARD_DEVIATION 21.25
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	1 Participants
Region of Enrollment United States	2 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 2
other Total, other adverse events	1 / 2
serious Total, serious adverse events	0 / 2

Outcome results

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.