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Completed

NCT Number: NCT04326452

Treating COVID-19 With a Bidirectional Oxygenation Valve

This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TMC HealthCare, Tucson, Arizona, United States

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About this study

We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Oxygen saturation <93%
  • Able to provide informed consent
  • Not currently requiring intubation
  • Receiving oxygen by face mask

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

bidirectional oxygenation mouthpiece

Device

Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.

Primary outcomes

  1. Pulse oximetry level

    Time frame: Change from Baseline pulse oximetry level at 15 minutes post treatment

    The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve

Secondary outcomes

  1. Respiratory rate

    Time frame: Change from Baseline clinical measurements at 15 minutes post treatment

  2. Heart rate

    Time frame: Change from Baseline clinical measurements at 15 minutes post treatment

  3. Blood pressure

    Time frame: Change from Baseline clinical measurements at 15 minutes post treatment

  4. Systemic carbon dioxide

    Time frame: Change from Baseline clinical measurements at 15 minutes post treatment

    Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.

Sponsors and collaborators

Lead sponsor

TMC HealthCare

Other

Collaborators

  • PEEP Medical, LLC

Registry information

Official study title

The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
May 4, 2022

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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