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

NCT04331366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-02-18

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Jeffrey Miller, MD · Emory University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2020-08-31
Completion
2020-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331366 on ClinicalTrials.gov