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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with GO2 PEEP MOUTHPIECE | Experimental | Participants receiving treatment with the GO2 PEEP MOUTHPIECE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GO2 PEEP MOUTHPIECE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Miller, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States | ||
| Emory St. Joseph's Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | GO2 PEEP MOUTHPIECE | Participants receiving treatment with the GO2 PEEP MOUTHPIECE. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GO2 PEEP MOUTHPIECE | Participants receiving treatment with the GO2 PEEP MOUTHPIECE. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends) |
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Participants were assessed for adverse events on the day of the intervention beginning just prior to treatment with the mouthpiece through 15 minutes after the cessation of PEEP therapy, for a total of up to 30 minutes.
Participants were assessed for the following adverse events:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GO2 PEEP MOUTHPIECE | Participants receiving treatment with the GO2 PEEP MOUTHPIECE. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decrease in oxygen saturation after cessation of PEEP therapy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Miller, MD | Emory University | 404-778-7200 | jeffrey.miller@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 | Jan 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
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) |
| 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) |
| 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) |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Respiratory Rate | The number of breaths per minute was assessed before treatment, during treatment, and 15 minutes after the end of treatment. | Posted | Mean | Standard Deviation | breaths per minute | Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends) |
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| Secondary | Heart Rate | Heart rate, in beats per minute, was assessed before treatment, during treatment, and 15 minutes after the end of treatment. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends) |
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| Secondary | Blood Pressure | Systolic and diastolic blood pressure was assessed before treatment, during treatment, and 15 minutes after the end of treatment. | Posted | Mean | Standard Deviation | mmHg | Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends) |
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| 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. | Data on subjective work of breathing were not collected at the Baseline and Minute 30 time points. | Posted | Count of Participants | Participants | Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends) |
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| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Minute 15 |
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| Minute 30 (15 minutes post-treatment) |
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| Minute 15 |
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| Minute 30 (15 minutes post-treatment) |
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| Minute 5 Diastolic |
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| Minute 10 Systolic |
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| Minute 10 Diastolic |
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| Minute 15 Systolic |
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| Minute 15 Diastolic |
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| Minute 30 (15 minutes post-treatment) Systolic |
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| Minute 30 (15 minutes post-treatment) Diastolic |
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| Minute 10 |
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| Minute 15 |
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| Minute 30 (15 minutes post-treatment) |
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