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GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

NCT04253834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-02-15

Study results available
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Summary

This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.

Conditions

  • Postoperative Atelectasis

Interventions

DEVICE

Incentive spirometer

The incentive spirometer is a device that measures how deeply a person can inhale (breathe in). It helps with taking slow, deep breaths to expand and fill the lungs with air, which helps prevent lung problems, such as pneumonia. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator to help users control their breathing.

DEVICE

GO2 Mouthpiece

The GO2 Mouthpiece is a simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath.

Sponsors & Collaborators

  • PEEP Medical, LLC

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Jeffrey Miller, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2021-01-31
Completion
2021-01-31
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 NCT04253834 on ClinicalTrials.gov