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Completed

NCT Number: NCT04331366

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Oxygen Saturation by Pulse Oximetry

    Time frame: 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 outcomes

  1. Respiratory Rate

    Time frame: 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.

  2. Heart Rate

    Time frame: 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.

  3. Blood Pressure

    Time frame: 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.

  4. Count of Participants With Subjective Work of Breathing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: GO2 PEEP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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