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

NCT04331366 | Completed Results FDA Device

• 1 other identifier: STUDY00000381
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief 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

COVID-19

Keywords

Bidirectional oxygenation; Pulmonary compromise; Supplemental oxygen

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Respiratory Rate

  Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)

• Heart Rate

  Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)

• Blood Pressure

  Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)

• Count of Participants With Subjective Work of Breathing

  Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)

Study Arms (1)

Treatment with GO2 PEEP MOUTHPIECE

EXPERIMENTAL

Participants receiving treatment with the GO2 PEEP MOUTHPIECE

Device: GO2 PEEP MOUTHPIECE

Interventions

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.

Treatment with GO2 PEEP MOUTHPIECE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 positive
• Oxygen saturation \<92%
• Able to provide informed consent
• Receiving oxygen by non-rebreather mask
• Not currently requiring intubation

You may not qualify if:

• Unable or unwilling to provide informed consent
• Cognitive impairment
• Rapidly decompensating status requiring urgent or emergent higher level of care

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jeffery Miller, MD
• Organization: Emory University

jeffrey.miller@emory.edu

404-778-7200

Study Officials

• Jeffrey Miller, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: April 8, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)