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Treating COVID-19 With a Bidirectional Oxygenation Valve

NCT04326452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Coronavirus Infection

Interventions

DEVICE

bidirectional oxygenation mouthpiece

Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.

Sponsors & Collaborators

  • PEEP Medical, LLC

    collaborator INDUSTRY

  • TMC HealthCare

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-27
Primary Completion
2021-03-27
Completion
2021-03-27
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04326452 on ClinicalTrials.gov