GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

NCT04253834 | Completed Results FDA Device

• 1 other identifier: IRB00117254
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiac surgery; Coronary bypass; Heart valve replacement; Postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• Partial Pressure of Oxygen (PaO2 Level)

  Partial pressure of oxygen is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood. Normal values are 80 to 100 millimeters of mercury (mmHg).

  1, 6, 12 and 24 hours postextubation

Secondary Outcomes (7)

• Number of Participants With Normal Atelectasis Score

  Immediately postoperative, Postoperative days 1, 2, 3, 4

• Oxygen Requirement

  Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4

• Carbon Dioxide Level

  Postextubation Hours 1, 6, 12 and 24

• FEV1

  Preoperative and postoperative day 3

• Forced Vital Capacity (FVC)

  Preoperative, Postoperative Day 3

Study Arms (2)

Incentive Spirometer Control Arm

ACTIVE COMPARATOR

Participants assigned to use the incentive spirometer after surgery.

Device: Incentive spirometer

GO2 Mouthpiece

EXPERIMENTAL

Participants assigned to use the Bidirectional Oxygenation Valve (GO2 Mouthpiece) after surgery.

Device: GO2 Mouthpiece

Interventions

Incentive spirometer DEVICE

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.

Incentive Spirometer Control Arm

GO2 Mouthpiece DEVICE

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

Also known as: Bidirectional Oxygenation Valve

GO2 Mouthpiece

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery
• Able to provide written informed consent
• Maintenance of an arterial line postoperatively

You may not qualify if:

• Active smoking, within three months of surgery
• Forced expiratory volume in one second (FEV1) \<75% predicted
• Relative risk to develop pulmonary barotrauma as evident by history of pneumothorax or emphysema
• Unable or unwilling to provide informed consent, cognitive impairment

Sponsors & Collaborators

• Emory University: lead
• PEEP Medical, LLC: collaborator

Study Sites (1)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Results Point of Contact

• Title: Dr. Jeffrey Miller
• Organization: Emory University

jeffrey.miller@emory.edu

404-252-6104

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: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single center, prospective, randomized controlled study

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 5, 2020
• Study Start: August 27, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 15, 2022
• Results First Posted: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)